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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY 3M NEXCARE ACTIVE WATERPROOF BANDAGES -2" X 4" KNEE AND ELBOW; BANDAGE, ELASTIC
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3M COMPANY 3M NEXCARE ACTIVE WATERPROOF BANDAGES -2" X 4" KNEE AND ELBOW; BANDAGE, ELASTIC Back to Search Results
Model Number 17354M
Device Problem Insufficient Information (3190)
Patient Problems Laceration(s) (1946); Laceration(s) (1946); Rash (2033); Rash (2033); Skin Erosion (2075); Skin Erosion (2075); Reaction (2414); Reaction (2414); No Information (3190)
Event Date 07/07/2018
Event Type  Injury  
Event Description
I experienced a severe rash with skin loss from use of 3m nexcare bandages.The rash covered several square inches of my arm around the area where the bandage adhesive had been touching my skin.I subsequently lost several layers of skin in that area.The bandage rash was similar to a chemical burn.The bandage rash covered an area at about 20 times the size of the three one inch long separate lacerations that i was bandaging.The bandage rash appeared on about (b)(6) 2018.And as of (b)(6) 2018, the bandage rash has still not completely healed.The adverse reaction of bandage rash was reported to 3m nexcare in (b)(6) 2018.And, sample bandages were mailed to 3m nexcare on about (b)(6) 2018.
 
Event Description
Add'l info received from reporter on august 25, 2018.F/u report access number: mw5078929.I have numerous photos of bandage rash.But, i'm not sure how to submit the photos to fda.The bandage rash lasted 3 weeks.3m, the mfr, did not take the problem seriously.In fact, they claimed that i was the only person who had reported bandage rash associated with those particular bandages.And, they just blew me off.
 
Event Description
I experienced a severe rash with skin loss from use of 3m nexcare bandages.The rash covered several square inches of my arm around the area where the bandage adhesive had been touching my skin.I subsequently lost several layers of skin in that area.The bandage rash was similar to a chemical burn.The bandage rash covered an area at about 20 times the size of the three one inch long separate lacerations that i was bandaging.The bandage rash appeared on about (b)(6) 2018.And as of (b)(6) 2018, the bandage rash has still not completely healed.The adverse reaction of bandage rash was reported to 3m nexcare in (b)(6) 2018.And, sample bandages were mailed to 3m nexcare on about (b)(6) 2018.
 
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Brand Name
3M NEXCARE ACTIVE WATERPROOF BANDAGES -2" X 4" KNEE AND ELBOW
Type of Device
BANDAGE, ELASTIC
Manufacturer (Section D)
3M COMPANY
st. paul MN
MDR Report Key7762360
MDR Text Key116546223
Report NumberMW5078929
Device Sequence Number0
Product Code FQM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 08/25/2018
2 Devices were Involved in the Event: 1   2  
2 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number17354M
Device Catalogue NumberNEXCARE CASE# 4251624
Device Lot Number00077533
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Other;
Patient Weight95
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