MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for 3M NEXCARE ACTIVE WATERPROOF BANDAGES -2" X 4" KNEE AND ELBOW 17354M NEXCARE CASE# 4251624 manufactured by 3m Company.
[116546223]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078929 |
| MDR Report Key | 7762360 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-25 |
| Date of Event | 2018-07-07 |
| Date Added to Maude | 2018-08-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3M NEXCARE ACTIVE WATERPROOF BANDAGES -2" X 4" KNEE AND ELBOW |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-08-07 |
| Model Number | 17354M |
| Catalog Number | NEXCARE CASE# 4251624 |
| Lot Number | 00077533 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | ST. PAUL MN US |
| Brand Name | 3M NEXCARE ACTIVE WATERPROOF BANDAGES -2" X 4" KNEE AND ELBOW |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-08-07 |
| Model Number | 00077533 |
| Lot Number | 17354M |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Other | 2018-08-07 |