MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blister (4537)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The following information has been received.Surgeon opined the reaction was due to the patient¿s allergy to pressure sensitive adhesives and that he was not concerned.Additional information requested however not received.Device will not been returned.If further details are received at a later date a supplemental.Name of orthopedic procedure? date of procedure? date of reaction? is a photo available of the reaction? it was noted that medication was prescribed, please provide medication name/type? were any other medical or surgical interventions performed? please describe how the adhesive was applied.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? 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? patient demographics: initials / id, gender, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? can you identify the product code and lot number of the product that was used? what is the current status of the patient? what is the physician¿s opinion on the causal relationship to the product?.

Event Description

It was reported a patient underwent an unknown orthopedic procedure on an unknown date and topical skin adhesive with mesh was used.Post operatively the patient experienced blister like reactions.Patient was given an unknown prescription to treat the reaction.Patients current status is unknown.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 3/3/2021.Additional information has been requested and obtained.Can you identify the product code and lot number of the product that was used? no.What is the current status of the patient? no additional treatment was needed outside of the prescription by surgeon.What is the physician¿s opinion on the causal relationship to the product? he is still using the product ¿ believes this was due to patient sensitivity.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11341232
• MDR Text Key: 241441065
• Report Number: 2210968-2021-01529
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention