In fda's medical device reporting for manufacturers' document issued on (b)(6) 2016, a "serious injury" is an injury or illness that is life threatening, results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent damage to a body structure.' if this malfunction was to recur, in the worst case, it could lead to an infection that could require medical intervention.This malfunction will be reported as the chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote.However, there was no serious injury associated with this event.
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The distributor initially reported a post-operative infection with the use of primaseal post-op dressing, with poor adherence of the dressing.The distributor then clarified there was no infection, only a concern about possible infection due to lack of adhesion of the dressing.There are 4 dressings associated with the complaint.It is undetermined whether the 4 dressings related to 4 different patients or 1 patient.Therefore as a precautionary measure this event is being reported 4 times.
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