MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Catalog Number CLR602

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

Patient Problems Burn(s) (1757); Hypersensitivity/Allergic reaction (1907)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The following additional information has been requested but no response received to date: is a photo available of the reaction? describe the reaction (e.G.Blister/red/infected/mild¿) what medical / surgical treatment was provided to treat the reaction? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over during application? 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? what is the physicians opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi, patient pre-existing medical conditions (ie.Allergies, history of reactions) 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? 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.

Event Description

It was reported a patient underwent a mammaplasty procedure on (b)(6) 2019 and topical skin adhesive was used.Post operatively, the patient had an allergic reaction on left breast and nipple burn following use.The doctor removed the product after 21 days of the procedure.Patient used kollagenase ointment and the appearance improved.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9111566
• MDR Text Key: 162507340
• Report Number: 2210968-2019-88040
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

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
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: CLR602
• Device Lot Number: MPH965
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention