MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for 3M NEXCARE SOFT N' FLEX SOFT N' FLEX NATURAL FEEL BANDAGES manufactured by 3m Company.
[117900273]
I recently had shoulder surgery and after i was able to remove and replace the bandages. I purchased "3m nexcare soft 'n flex 2"x4" bandages" to cover the wound. I used them for 5 days, replacing them each morning. On (b)(6) 2018, i was removing the band-aid and the bandaged also removed the 1st layer of my skin, by approx 1 x 1 inch square. It immediately started bleeding and is extremely painful. Retailer: (b)(6). Retailer state: (b)(6). Purchase date: (b)(6) 2018. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079247 |
| MDR Report Key | 7801563 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-07-16 |
| Date Added to Maude | 2018-08-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 SOFT N' FLEX |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-08-20 |
| Model Number | SOFT N' FLEX NATURAL FEEL BANDAGES |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Brand Name | 3M NEXCARE SOFT N' FLEX |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2018-08-20 |
| Model Number | SOFT N' FLEX NATURAL FEEL BANDAGES |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |