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U.S. Department of Health and Human Services

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

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J&J / ETHICON, INC. DERMABOND PRINEO SKIN CLOSURE SYSTEM CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Device Problems Fluid 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).
 
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Brand NameDERMABOND PRINEO SKIN CLOSURE SYSTEM
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
J&J / ETHICON, INC.
MDR Report Key13549513
MDR Text Key285827347
Report NumberMW5107539
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received02/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 02/16/2022 Patient Sequence Number: 1
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