MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for AMERIGEL HYDROGEL WOUND DRESSING "ADVANCED FORMULA" manufactured by Amerx Healthcare Corp..
[134179037]
After re-section of left large toenail, applied wound dressing and several days later, it began swelling and oozing. Skin appeared to be like necrosis. Wound had rancid smell. Stopped using gel. It does not appear to be healing despite amoxicillin antibiotics. Signs of skin infection like oozing, heat, swelling, redness, or pain. Nail resection of left large toenail. Did the problem stop after the person reduced the dose or stopped taking or using the product? No. How was it taken or used: 1 ounce(s), twice a day, topical. Date the person started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2019. Reason for use: wound treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083323 |
| MDR Report Key | 8274016 |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-21 |
| Date of Event | 2019-01-14 |
| Date Added to Maude | 2019-01-24 |
| 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 | 0 |
| Brand Name | AMERIGEL HYDROGEL WOUND DRESSING "ADVANCED FORMULA" |
| Generic Name | DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC |
| Product Code | MGQ |
| Date Received | 2019-01-23 |
| Lot Number | 760 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERX HEALTHCARE CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-23 |