(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.Initial procedure date? 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? was there any infection reported? if yes, was the site cultured? if so, what bacteria were identified? please provide photos (if not provided).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 event? 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/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
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Product complaint # pc-000083345 additional information was requested and the following was obtained: initial procedure date: unknown please describe how was the adhesive applied on the tape - 1 coating what prep was used prior to, during or after prineo use? duraprep and ioban was a dressing placed over the incision? if so, what type of cover dressing used? no was there any infection reported? no is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown is the patient hypersensitive to pressure sensitive adhesives? unknown were any patch or sensitivity tests performed? unknown do you have the lot number involved ? no what is the physicians opinion of the contributing factors to the event? surgeon thinks it¿s a mechanical issue with the tape what is the most current patient status? unknown is the product or representative sample (product from the same lot number) available for evaluation? no patient demographics: initials / id; age or date of birth; bmi ; gender unknown patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?unknown additional information: the doctor reported that the procedure was performed with 60 degree knee flexion and an aggressive motion protocol was used.
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