MAUDE Adverse Event Report: 3M COMPANY 3M NEXCARE ACTIVE WATERPROOF BANDAGES -2" X 4" KNEE AND ELBOW; BANDAGE, ELASTIC

Model Number	17354M
Health Effect - Clinical Codes	Laceration(s) (1946); Laceration(s) (1946); Rash (2033); Rash (2033); Skin Erosion (2075); Skin Erosion (2075); Reaction (2414); Reaction (2414); No Information (3190)
Date of Event	07/07/2018
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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 or Problem 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.

• Brand Name: 3M NEXCARE ACTIVE WATERPROOF BANDAGES -2" X 4" KNEE AND ELBOW
• Common Device Name: BANDAGE, ELASTIC
• Manufacturer (Section D): 3M COMPANY; st. paul MN
• MDR Report Key: 7762360
• Report Number: MW5078929
• Device Sequence Number: 16621559
• Product Code: FQM
• UDI-Device Identifier: 00051131997172
• UDI-Public: 051131997172
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 17354M
• Device Catalogue Number: NEXCARE CASE# 4251624
• Device Lot Number: 00077533
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/28/2018
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 95