MAUDE Adverse Event Report: J&J / ETHICON, INC. DERMABOND PRINEO SKIN CLOSURE SYSTEM; CUTANEOUS TISSUE ADHESIVE WITH MESH

Device Problems Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 02/14/2022

Event Type  Injury  

Event Description

I had surgery on (b)(6) 2022, the doctor closed the 4 inch incision using dermabond prineo skin closure system and placing a large waterproof bandage over the area.On (b)(6) 2022, i had a lot of itching, redness on the edge of the bandage and it appeared that water was getting through the bandage, so i removed the bandage.Over the next week the redness and itching got much worse.The doctor prescribed a cream, anti-itch pill, and an antibiotic to start taking on (b)(6) 2022.My 2 week post-op was on (b)(6) 2022, where the doctor said i had an allergic reaction.Fda safety report id # (b)(4).

Event Description

I had surgery on (b)(6) 2022, the doctor closed the 4 inch incision using dermabond prineo skin closure system and placing a large waterproof bandage over the area.On (b)(6) 2022, i had a lot of itching, redness on the edge of the bandage and it appeared that water was getting through the bandage, so i removed the bandage.Over the next week the redness and itching got much worse.The doctor prescribed a cream, anti-itch pill, and an antibiotic to start taking on (b)(6) 2022.My 2 week post-op was on (b)(6) 2022, where the doctor said i had an allergic reaction.Fda safety report id # (b)(4).

• Brand Name: DERMABOND PRINEO SKIN CLOSURE SYSTEM
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): J&J / ETHICON, INC.
• MDR Report Key: 13549513
• MDR Text Key: 285827347
• Report Number: MW5107539
• Device Sequence Number: 1
• Product Code: OMD
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White