Product complaint #: (b)(4).Additional information has been requested, with no further information provided.Please provide photos.Initial procedure date? how was the skin incision closed? what is meant by "fistula"? was the capsule of the knee closed adequately and how was it closed? does the pa believe the wound was adequately closed prior to the application of prineo? 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.Please indicate any medical or surgical interventions performed.What post op date did the reaction occur? please describe how was the adhesive was applied on the tape.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? do you have the lot number involved? what is the physicians opinion of the contributing factors to the reaction? 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 (ie.Allergies, history of reactions)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? to date device not received.If the device or further details are received at a later date a supplemental medwatch will be sent.
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