MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for COVIDIEN XEROFORM OCCLUSIVE GAUZE STRIP manufactured by Covidien.
[176281858]
Placed a piece of xeroform gauze over a superficial wound on my toe, covered it with a band aid, wore shoes for 4 hours. Took off my shoe, band aid was saturated, xeroform caused a full thickness burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092482 |
| MDR Report Key | 9628384 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-23 |
| Date of Event | 2019-12-22 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COVIDIEN XEROFORM OCCLUSIVE GAUZE STRIP |
| Generic Name | DRESSING WOUND DRUG |
| Product Code | FRO |
| Date Received | 2020-01-24 |
| Lot Number | 8010804 |
| Device Expiration Date | 2019-12-31 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Brand Name | 3% BISMUTH TRIBROM OPHENATE % PERCENT |
| Product Code | --- |
| Date Received | 2020-01-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | PUBLIX SUPERMARKETS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-24 |