MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-28 for ISOLATION GOWN W/THUMB LOOP NONTH100 manufactured by *.
[67337]
A nurse technician was wearing an isolation gown while bathing an infant under a radiant warmer when the sleeves on the gown started to melt. Technician went to the emergency room. Technician received first degree burns on both arms. Unable to determine if it was a medine distributed gown until 7/24/97. Unable to identify the mfr as no lot number was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-1997-00029 |
| MDR Report Key | 108499 |
| Date Received | 1997-07-28 |
| Date of Report | 1997-07-28 |
| Date of Event | 1997-06-24 |
| Date Facility Aware | 1997-07-09 |
| Report Date | 1997-07-28 |
| Date Reported to FDA | 1997-07-28 |
| Date Added to Maude | 1997-07-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | ISOLATION GOWN W/THUMB LOOP |
| Generic Name | ISOLATION GOWN W/THUMB LOOP |
| Product Code | FYC |
| Date Received | 1997-07-28 |
| Model Number | NA |
| Catalog Number | NONTH100 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 106638 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-28 |