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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY NEXCARE WATERPROOF BANDAGES; TAPE AND BANDAGE, ADHESIVE

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3M COMPANY NEXCARE WATERPROOF BANDAGES; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Peeling (1999); Superficial (First Degree) Burn (2685); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
Event Date 12/19/2023
Event Type  Injury  
Event Description
I had a burn on my arm from the corner of a hot pan.I covered it with a band-aid adhesive bandage overnight for 2 nights with no reaction.I wanted to use a bigger bandage, so i bought nexcare waterproof bandages on (b)(6) 2023 and applied one overnight.When i removed the bandage in the morning, the skin that was in contact with the adhesive was red and painful, and looked like i had a chemical burn.One side of the new wound also had little spots of blood and was oozing yellow fluid, and it appeared that the top layers of skin had come off along with the bandage.Over the next 6 days, most of the red skin turned hard and scaly, and it mostly peeled off on the 6th morning, but the side that was bleeding still shows deep tissue damage and is yellow in the middle where the skin is missing.I took photos of the wound.I have no known allergies.
 
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Brand Name
NEXCARE WATERPROOF BANDAGES
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
3M COMPANY
MDR Report Key18411292
MDR Text Key331639190
Report NumberMW5149653
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/27/2023
Patient Sequence Number1
Treatment
PRILOSEC
Patient Outcome(s) Other;
Patient Age46 YR
Patient EthnicityNon Hispanic
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