MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-03 for THERMACARE UNK manufactured by Proctor And Gamble.
[260174]
Pt used device because of low back pain. Family member purchased device for pt. Box says it gives heat for 7 hrs. At 11:30a pt put the device on. It was on until 6:30p and it burned the pt. A blister formed. Neosporin was applied but it did not help. A dr saw pt and diagnosed 2nd and 3rd degree burns. Mfr was notified. Rptr says box has no warning about possible burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026033 |
| MDR Report Key | 413731 |
| Date Received | 2002-09-03 |
| Date of Report | 2002-09-03 |
| Date of Event | 2002-08-01 |
| Date Added to Maude | 2002-09-03 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | HEATING PAD PETITE SIZE |
| Product Code | IMA |
| Date Received | 2002-09-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 402764 |
| Manufacturer | PROCTOR AND GAMBLE |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-09-03 |