(b)(4) date sent to the fda: 12/02/2016.(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.Lot number involved please provide photos of the reaction 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? was the dermabond liquid adhesive placed to cover the entire length of the mesh? 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.How large of an area does the reaction cover? did the skin reaction extend beyond the borders of the tape 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? results of allergy testing 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? please provide the specific number of patients that experienced similar reactions after knee or hip procedures.Please provide the following additional information for each patient event: 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? was the dermabond liquid adhesive placed to cover the entire length of the mesh? 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? lot number involved 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?.
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It was reported that the patient underwent a total knee replacement procedure on (b)(6) 2016 and the topical skin adhesive was used without incident.Following the procedure, the patient experienced a skin reaction including blistering, itching, and a raised skin reaction.On (b)(6) 2016 the patient developed redness and itching at the site and superficial serous drainage.The topical skin adhesive was removed and the patient was prescribed medrol dose pack and instructed to take oral benadryl as needed and to leave the site uncovered.The reaction improved and no further intervention was necessary.The patient has recovered and is following up with an allergist later this month to undergo skin testing to identify the source of the reaction.Additional information has been requested.
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