(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 do you have any photos? what was the angle of the knee during application? was tension reviewed before applying the mesh? procedure date date that blistering was noticed? what prep was used prior to prineo use? please describe how the adhesive was applied on the tape? was the dermabond liquid adhesive placed to cover the entire length of the mesh? did the prineo mesh extend beyond the patient incision? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and allowed to dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? what does the reaction look like? please provide details.What type of medication? dose? when (date) administered? was the product removed? was another method used to close the incision? is the patient hypersensitive to pressure sensitive adhesives? lot number involved what is the physicians opinion of the contributing factors to the blistering ? 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.
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