MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Model Number CLR422US

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Swelling (2091)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Attempts to obtain the following information has been performed but not received.If the further details are received at a later date a supplemental medwatch will be sent photo of reaction? procedure name? procedure date? date reaction noted? was there any other treatment provided (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed) in addition to steroids? if so, please clarify please indicate any medical or surgical interventions performed.Please describe how was the adhesive was applied.What prep was used prior to, during or after dermabond advanced 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? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product lot available 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) was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? to date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent an unknown plastic surgery procedure on an unknown date and topical skin adhesive was used.Patient experienced severe reaction with swelling, redness under and around adhesive and pain.Steroids administered to treat additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Attempts to obtain the following information has been performed and the following was received.If the further details are received at a later date a supplemental medwatch will be sent unfortunately i have received no further information and i doubt i will be able to gather any more intel for you.I will let you know if anything changes.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9952843
• MDR Text Key: 187411798
• Report Number: 2210968-2020-02959
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031240421
• UDI-Public: 10705031240421
• Combination Product (y/n): N
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR422US
• Device Catalogue Number: CLR422US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention