Product complaint # (b)(4).The following additional information was requested and received: how was the reaction treated (product removed; prescription steroids; antibiotics prescribed; reoperation; reclosure;)? if so, please clarify.The reaction was treated with oral steroids.Were any patch or sensitivity tests performed? patch testing was not done (but will be).Patient demographics: initials / id; age or date of birth; bmi ; gender pg/age: (b)(6)/female.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure.I believe the product was used before.What is the most current patient status? patient status is reaction is resolved.Please be advised that i do not have access to most of the information you are asking.Attempts have been made to obtain the following information, however not received to date.Initial procedure date.Please describe how was the adhesive 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? patient pre-existing medical conditions (ie.Allergies, history of reactions).What is the physicians opinion of the contributing factors to the reaction? is the product or representative sample (product from the same lot number) available for evaluation? to date the device has not been returned and all of the additional information requested has not been received.If the device or further details are received at a later date a supplemental medwatch will be sent.
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