MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-30 for THERMACARE * manufactured by Proctor And Gamble.
[267737]
Pt used thermacare continuous heat wrap for low back pain. After 45 mins of wear, the wrap was uncomfortably hot, then a burning sensation began. Pt removed the product and noted first and second degree burns on their low back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026037 |
| MDR Report Key | 414722 |
| Date Received | 2002-08-30 |
| Date of Report | 2002-08-30 |
| Date of Event | 2002-07-11 |
| Date Added to Maude | 2002-09-09 |
| 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 |
| 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 | THERMACARE |
| Generic Name | CONTINUOUS TOPICAL HEAT TREATMENT DEVICE |
| Product Code | IMA |
| Date Received | 2002-08-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 403754 |
| Manufacturer | PROCTOR AND GAMBLE |
| Manufacturer Address | * CINCINNATI OH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-08-30 |