Handling Medical Device Product Complaints and Reporting - 30 Frequently Asked Questions and Expert Answers

    The moment a medical device is released into the market, manufacturers can expect to be flooded with customer complaints. The nature of a medical device - complexity and potential for misuse - makes this possible. So, companies have to implement an efficient complaint handling system much before the product is marketed. The various elements, personnel and processes involved in complaint handling and management throw up various doubts and queries, capable of stalling operations at even the most established device companies.

    What should be reported to the regulators and when? Who, specifically, should be given training in handling complaints? What is complaint trending and what tools should be used? These are just some of the real-life questions that can baffle device professionals and we have compiled several of these queries and expert solutions to each in this document.



    Q1. What is a complaint?

    A complaint is a written, electronic or oral communication that alleges deficiencies in the following with regard to a medical device:

    • Identity
    • Quality
    • Durability
    • Reliability
    • Safety
    • Effectiveness
    • Performance

    Q2. What exactly is an MDR event?

    An MDR event, according to the regulations, is one that has caused or contributed to a death or serious injury. The regulations further define a serious injury as one that:

    • Is life threatening
    • Is the cause of permanent impairment of a body function or permanent damage to body structure
    • Requires medical intervention to avoid permanent impairment to a body function or permanent damage to body structure


    Q3. When should adverse events be reported to the FDA or MDD? When does the clock start for the time in which such reports should be submitted to agencies?

    The clock starts the moment someone at the regulated firm becomes aware of an event/ issue that has adverse consequences for the user. This is a very strict requirement and one the agencies expect manufacturers/ regulated companies to follow.

    Q4. If a device user does not use the product carefully and it results in an adverse event, would this still have to be reported by the manufacturer?

    Yes, the FDA definitely would require incidents of this type to be included in the MDR. They should be thoroughly investigated - it's simply not enough to label it as user error. The error might have resulted from some product defect and the agency most definitely would need a concrete answer as to why the incident occurred - whether because of the operator or the device itself.

    Q5. In case a diagnostic tool/software used by physicians results in a serious adverse event that is reportable, how does the manufacturer find out about it?

    Usually, the physician will report an event to either the company or she/he will file an MDR with the FDA. In the latter case, the agency will send a copy of the MDR to the company

    Q6. If the adverse event reported is one that is known and listed on the product label, will it still have to be investigated?

    No. But make sure that the report reflects the incident complete in all particulars, even to its degree. If the product label for example lists skin irritation as an adverse reaction to the product, ensure that the reported complaint is the same and is not a more severe reaction to the product. That is, it is within the limitation of the expected adverse event.

    Q7. If a serious adverse event is reported for a device in Europe that has been cleared for both the EU and US markets, would an MDR have to be filed in the US as well?

    No - an MDR has to be filed for only adverse events that take place in the US.

    Q8. Is super reporting and summary reporting similar?

    No - they are two different things. Summary reporting may be annual which gives a brief overview of number of complaints falling into a certain category, how they were resolved etc. Super investigations are internal reports that are used to categorize/ group together those investigations that have a common theme.

    Q9. If the use of a medical device results in death, how soon is the MDR to be submitted?

    The MDR should be filed with the FDA within 5 workdays.

    Q10. If a serious injury is reported upon the use of a device, within how many days is the MDR to be submitted?

    The MDR should be submitted to the FDA within 30 calendar days.

    Complaint Handling

    Q11. In the case of a firm that receives on aggregate 40,000 complaints a year, is it enough just to interview the complainant or document the complaint onsite with respect to an investigation? Is this enough in the eyes of the FDA?

    The FDA is not concerned with numbers or cost. A best practice would be to trend the types of complaints, the kinds of investigations carried out and so on during the management reviews that should be done more than once a year. A summary of this information should be provided during the reviews. The FDA would require detailed explanations for the trends and investigations carried out, so it best to detail these.

    Q12. How should CRM software for complaint management be chosen?

    The software should cover the complaint process from A to Z and the complaint once entered, can only be modified by those with the right credentials. For example, once the customer service person documents the complaint and saves it, it should be ensured that this section is not modifiable. So the software should have components that allow complaint entry, investigation assignment, corrective actions, and any conclusion and so on.

    Q13. What is the difference between "correction taken" and "corrective action taken"?

    In terms of complaint responses, a correction is pretty much useless. In the case of single use devices, once it's used, it's disposed - so there's no possibility of a correction being done. In the case of multiple use devices, if a product is returned for replacement of parts, then a repair is done, not a correction.

    If a product is being investigated, then the person doing the investigation will ask the following question - "Does the issue happen a lot?" If yes, then a corrective action will need to be taken to fix the problem proactively.

    So, in the complaint management scenario, it's not possible for a "correction" to be made. But a "corrective action" is a fundamental step to solving issues with a product.

    Q14. Is there any difference to handling complaints reported in clinical trials and those relating to approved products?

    No - there isn't a difference. Complaints are feedback from the field and have to be treated the same.

    Q15. Should complaint handling training be provided only to the department personnel in charge of handling customer feedback?

    No - it should be done for all personnel across the company. Anyone who answers the phone should be given training in complaint handling - for example, even receptionists or telephone operators.

    Q16. A brand-new product has just been launched and the company has been inundated with complaints. If the company has no resources to handle the volume of complaints, what should be done to make the process more manageable?

    A best practice in such cases would be to organize the complaints into different super groups, based on the type of complaint. This will make it easier to investigate each complaint in detail.

    Q17. When should a complaint be considered "closed"?

    There is no FDA regulation that defines when a complaint is considered "closed". So, a company will have to come up with its own definitive guidelines of when and how a complaint is considered as closed. Some of the scenarios which may signal that a complaint is closed include:

    • When the investigation has been assigned (but the complaint status should be updated until the investigation is actually completed)
    • When the investigation has been completed
    • When the corrective action has been determined (the complaint status should be updated until the corrective action is completed)
    • When the corrective action has been completed successfully


    The best tool would be a Pareto chart. It is ideal to trend complaints by model per month. The reviews should be done quarterly, allowing for proper examination of complaint trends per model.

    Q19. Is there a specific limit (number of complaints) at which action has to be taken to address issues?

    No, there is not. The usual practice is to take action when an inordinate number of complaints are received. There is no fixed number or limits defined by the FDA or other agencies for this. If the number of complaints exceeds a certain limit fixed by the firm/manufacturer itself as an unacceptable limit, then trending should be done in order to analyze what exactly is happening and if action needs to be taken. If the number of complaints per percentage of units sold is high and compares unfavorably with similar product models, then corrective action at a high level needs to be undertaken, involving engineering, R&D and so on.

    Documentation and Retention

    Q20. What is the retention period for a complaint?

    A complaint should be retained for at least three years beyond the use life of a product. The use life of a product is the responsibility of the company to determine and document. It's different from the warranty period of the product.

    Q21. How do you document complaints that come to a company via a medium other than the 1-800 number specifically designated for customer complaints?

    If a complaint is written in, it should be added to the 1-800 database. If they come in verbally, put them into writing and transfer them to the responsible personnel.

    Q22. Should all negative feedback be documented when received?

    Yes, any negative feedback received should be documented.

    Q23. A customer complains about a product and in order to thoroughly investigate the complaint, the manufacturer requests that the product be shipped back so this can be done. However, the customer refuses to ship the product. What should be done in cases such as this?

    In such a situation, it is best to do a document review. Take the serial number of the product from the customer and look at the device history record. Look at the parts that were issued, the testing done, review the complaints and examine trends. Note down all this in the report, including whether the issue is something highlighted for the first time or whether it is something that has been cropping up frequently. In this manner, the investigation can be completed without actually having to test the faulty product.

    Q24. What is to be done if the returned product is received after the complaint has been closed?

    It is a best practice to reopen the complaint and evaluate it. There's nothing wrong with reopening a complaint based on additional information.

    Complaint or Feedback

    Q25. If a customer orders a product but it is not delivered within the promised delivery time, would the call reporting this be considered a complaint?

    No, this would not be considered a complaint. But it would need to be documented so that the firm's shipping and delivery department/vendor is aware of the delay.

    Q26. Is dissatisfaction expressed by a customer about a company employee a complaint?

    No, that would not be a product complaint. This would come under what most firms call customer feedback.

    Q27. If the customer demands a new feature in a product, would this be a complaint?

    No, this would be classified under customer feedback. It is not a complaint about the product if the customer says that he/she wishes the product did something more than it claims to do.

    Q28. Is it enough to just take a complaint when the customer says, "It doesn't work"?

    Customer service personnel should be trained to ask more detailed questions about the product so that sufficient information about the defect/deficiency is recorded in order to investigate the complaint. It is not enough to record "It doesn't work" in the complaint form.

    Service Request

    Q29. Should the approach to tracking a service request be the same as that of a complaint?

    If the company receives a service call, then it should be evaluated to see if it is reportable or not. If it is not specifically a complaint and is only a service issue, then this would need to be tracked and entered into the complaint database. A complaint number would have to be assigned, even though it is just a service issue.

    Q30. In the case of repeatable use devices, at what point does a service call become a complaint or service issue due to deterioration?

    In such cases, the firm should define what constitutes a complaint or a service issue in the complaint handling and service procedures. So, an initial call can be treated as a complaint, but subsequent calls are considered service issues.

    Gain a better understanding of medical device regulatory requirements by attending the following ComplianceOnline webinars

    Spotlight on Complaint Handling and Medical Device Reporting

    Post-Market Requirements, Complaint Handling, MDD and MDR

    Medical Device Complaint Handling | MDRs and Recalls