MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-07 for AMERIGEL manufactured by Amerx Health Care Corp.
[44909378]
I was prescribed this med for a toe ulcer. My leg started getting swollen and red. Doctor told me it was normal swelling. Eventually the infection took over and my toe grew 4 times its size... Had gangrene.. Lost the front of my foot thanks to this stuff not doing its job. I was never informed about the recall!!!
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062165 |
| MDR Report Key | 5646238 |
| Date Received | 2016-05-07 |
| Date of Report | 2016-05-07 |
| Date of Event | 2014-06-12 |
| Date Added to Maude | 2016-05-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 | 3 |
| Brand Name | AMERIGEL |
| Generic Name | AMERIGEL |
| Product Code | MGQ |
| Date Received | 2016-05-07 |
| Lot Number | 3WD05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERX HEALTH CARE CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-07 |