MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-31 for WASH AND CARE * 31403788 manufactured by Graphic Controls Corp..
[163454]
Wash and care put in microwave to heat. Employee "intended" to set microwave for 20 secs, and walked away. Mocrowave apparently set for 2 mins. Package melted with smoke and very toxic fumes. Presented a safety hazard to staff as well as pts in the area. Exhaust fans used to clear smoke and fumes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016112 |
| MDR Report Key | 218353 |
| Date Received | 1999-03-31 |
| Date of Report | 1999-03-29 |
| Date of Event | 1999-03-24 |
| Date Added to Maude | 1999-04-14 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WASH AND CARE |
| Generic Name | DISPOSABLE WASH CLOTHS |
| Product Code | KME |
| Date Received | 1999-03-31 |
| Model Number | * |
| Catalog Number | 31403788 |
| Lot Number | * |
| ID Number | 810 WASH AND CARE PREMIUM SET |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 211765 |
| Manufacturer | GRAPHIC CONTROLS CORP. |
| Manufacturer Address | 9530 DESOTO AVE. CHATSWORTH CA 913115084 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-03-31 |