(b)(4) date sent to the fda: 08/17/2016.(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/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
|