(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.Additional information was requested and the following was obtained: the knee capsule is closed with stratafix.The leg is at approximately 45 degree angle for suture and prineo application.Knees are covered with ace bandage post op.Fluid filled blisters are seen only at the distal end of the prineo.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.Please provide photos.Please provide additional event description for each patient.Initial procedure date.What date did the reaction occur post op? how was the reaction treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify.Do you have the product code and lot number involved.What is the physicians opinion of the contributing factors to the blisters / reaction? 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.Any update to patient current condition.
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