MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

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

Patient Problems Itching Sensation (1943); Local Reaction (2035)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information has been requested and obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.What is the procedure date? (b)(6).What date did the reaction occur on? a week later.What does the reaction look like and how large of an area does the reaction cover? red, covers entire mesh.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Yes, removed product, prescribed oral antihistamine, steroid cream to place on skin not on the incision, placed steri strips to cover wound.What is the most current patient status? stable.Can you identify the lot number of the product that was used? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.Please describe how was the adhesive was applied.Per ifu guidelines.What prep was used prior to, during or after prineo use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? no dressing, just an ace bandage wrap for compression is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? yes placed product on wrist prior to surgery to see if there was a reaction.Patient demographics: initials / id, age or date of birth; bmi unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown.Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a total hip replacement on (b)(6) 2020 and topical skin adhesive with mesh was used.Post-operatively the patient had contact dermatitis.The area around the mesh was red and itchy.This was noted during a visit with the physicians assistant, two weeks after the procedure.The adhesive was removed, prescribed oral antihistamine, steroid cream to place on skin not on the incision, placed steri strips to cover wound.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876
• MDR Report Key: 10907314
• MDR Text Key: 218511347
• Report Number: 2210968-2020-09309
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention