I agree that an MDR must be filed for a serious injury report, even if it was off-label use. From a legal and ethical standpoint, you should also send a written letter to the customer stating that this was a situation of off-label use, and that the health professional should discontinue the use of the product in this manner.
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Christine Posin RAC
Consultant
Walnut CA
United States
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Original Message:
Sent: 04-19-2013 11:48
From: Jason Gumaer, MPH
Subject: Off-label Use
Ponzelle
There are at least two steps you need to perform. First, evaluate the incident for MDR. The FDA has cited firms for failing to report incidents that they considered "not their fault" (including an incident where a scalpel was dropped and damaged). Second, look at your risk assessment and see if you could have done anything to reasonably prevent the off label use. As always, document the results. Best of luck.
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Jason Gumaer, MPH
Therapak Corporation
Duarte CA
United States
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Original Message:
Sent: 04-18-2013 14:09
From: Ponzelle Royster
Subject: Off-label Use
When a device is used off-label and has been reported to have resulted in injury as a result of the off-label use, do medical device manufacturers have any other compliance obligations other than ensuring that they are not promoting this off-label use. I cannot find a regulation on further remedies.
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Ponzelle Royster RAC
Duluth GA
United States
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