MAUDE Adverse Event Report: J&J / ETHICON, INC. DERMABOND; TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN

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

Patient Problem Contact Dermatitis (4546)

Event Date 12/01/2022

Event Type  Injury  

Event Description

I underwent a surgery on (b)(6) 2022 and my surgeon used dermabond (surgical glue).I had severe contact dermatitis on (b)(6) 2022.Surgical glue to close wound.

• Brand Name: DERMABOND
• Type of Device: TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN
• Manufacturer (Section D): J&J / ETHICON, INC.
• MDR Report Key: 16832889
• MDR Text Key: 314289739
• Report Number: MW5117111
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: LACOSAMIDE; NUTRAFOL; SLYND
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White