MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-19 for NEXCARE BANDAGES manufactured by 3m.
[86976391]
I used a nexcare bandaid on a cut and the bandaid burned my skin. Had an infection and now have a scar. Had to go to the emergency room twice as it was not getting better. I have contacted 3m-nexcare and they are not responding to me. I have given them everything they have asked for and they tell me they will call me back and they never do. "is the product over-the-counter: yes; how was it taken or used: topical; did the problem stop after the person reduced the dose or stopped taking or using the product: no. " dates of use: (b)(6) 2017. Reason for use: covering a cut.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | MW5072239 |
| MDR Report Key | 6879496 |
| Date Received | 2017-09-19 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-05-12 |
| Date Added to Maude | 2017-09-20 |
| 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 | NEXCARE BANDAGES |
| Generic Name | BANDAGE, LIQUID |
| Product Code | KMF |
| Date Received | 2017-09-19 |
| Lot Number | 15087B |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Other | 2017-09-19 |