Product complaint # (b)(4).The following additional information was requested, however not received to date: initial procedure date what date did the reaction occur post op? it was noted that prednisone was prescribed, was the reaction treated in any other manner (product removed; reoperation; reclosure; antibiotics prescribed)? if so, please clarify please indicate any medical or surgical interventions performed? 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/demabond or skin adhesive used on the patient in a previous surgery or wound closure? what was the angle of the knee during application (if applicable)? attempts have been made to obtain additional information.To date the device has not been returned and no additional information has been received.If the device or further details are received at a later date a supplemental medwatch will be sent.
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It was reported a patient underwent a total knee procedure on an unknown date and topical skin adhesive was used.The patient returned, eight days post-operatively, with an allergic reaction.The patient was prescribed prednisone to clear the allergic reaction.Additional information has been requested.
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