(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.What characteristics prompted the physician to believe that the patient had allergic reaction to the prineo? please explain the reason that patient was brought back to or to have the prineo removed? please explain any medical or surgical interventions performed? please provide photos what date did the reaction occur post op? how was the reaction treated (prescription steroids; antibiotics prescribed)? what was the angle of the knee during application? 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? were any patch or sensitivity tests performed? 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) for female patients ask: was the patient exposed to similar products, such as artificial nails was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.
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