MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-24 for THERMACARE * manufactured by Procter & Gamble Paper Product Co.
[295035]
The consumer left city via automobile to drive to another city. They were experiencing lower back pain and went to the local store and purchased the thermacare heat wraps. The complainant stated they read the instructions, which mentioned the product could be used up to 8 hours and one can get the best use from product by sitting for long periods of time. They put one wrap on. They drove 6 hours and stopped for the night. They removed the wrap and complained their back felt hot. When they looked at the area where they used the product they had five red burn marks. That evening consumer couldn't sleep as their back hurt badly. The next morning their hostess checked consumer's back and saw large blisters. They were in such pain that their host offered to drive them back home and a neighbor drove the host car to follow-up the host back to their home. The complainant visited doctor. The doctor examined their back and said that they had 2nd and 3rd degree burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003587 |
| MDR Report Key | 487718 |
| Date Received | 2003-09-24 |
| Date of Report | 2003-08-20 |
| Date of Event | 2002-03-25 |
| Date Added to Maude | 2003-10-09 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | LOWER BACK HEATWRAP |
| Product Code | IMA |
| Date Received | 2003-09-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 476582 |
| Manufacturer | PROCTER & GAMBLE PAPER PRODUCT CO |
| Manufacturer Address | 512 LIBERTY EXPY SE ALBANY GA 317054147 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-09-24 |