MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-15 for DURO-MED MOIST HEAT PAD 4503 NA manufactured by Duro-med Industries, Inc..
[17178694]
The claimant alleges that she bought a heating pad and it blew up in her microwave and she got 2nd degree burns on her arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32649-1998-90001 |
| MDR Report Key | 163093 |
| Date Received | 1998-04-15 |
| Date of Report | 1998-04-15 |
| Date of Event | 1998-03-29 |
| Date Reported to Mfgr | 1998-03-30 |
| Date Added to Maude | 1998-04-21 |
| 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 |
| 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 | DURO-MED MOIST HEAT PAD |
| Generic Name | NA |
| Product Code | IMA |
| Date Received | 1998-04-15 |
| Model Number | 4503 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | ECONO #353-9292 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 158776 |
| Manufacturer | DURO-MED INDUSTRIES, INC. |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-04-15 |