(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Initial procedure date.Do you have a photo of the second patient event? date that the prineo came off.Event date that the wound opened? date of reoperation.Did the entire wound dehisce or was the dehiscence superficial? what is the physicians opinion of the contributing factors to the wound opening? was there any precipitating stress factor for wound opening ? what prep was used prior to prineo use? please describe how the adhesive was applied on the tape? was incision re-prepped before closure? if so, with what? was a dressing placed over the incision? if so, what type of cover dressing used? please explain how the skin was closed? what was the angle of the knee during application? what was done to address the wound opening? please describe any medical or surgical interventions performed was any medication prescribed? dose? when (date) administered? lot number involved.What is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi; gender.Patient pre-existing medical conditions.
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