(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Procedure name; procedure date; location and incision size of product application?; what prep was used prior to prineo use?; was the prep allowed to dry prior to prineo mesh application?; please describe how the adhesive was applied on the tape?; when applying are they completely covering the edge of the mesh with prineo?; was the mesh placed over the entire length of the incision?; 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?; date of reaction; what does the reaction look like? please provide details.; how large of an area does the reaction cover?; did the skin reaction extend beyond the borders of the tape; do you have any pictures of the reaction?; what was done to address the reaction? ; what type of medication? dose? when (date) administered?; was the product removed? was another method used to close the incision?; was the site cultured? if so, what bacteria were identified?; 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?; 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 : 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?.
|