MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-25 for THERMAL CARE 4841812 manufactured by Procter & Gamble Co..
[20433056]
Pt used the thermal care for their back problem. The thermal care caused them to have burns on their back. Pt had to apply cream for two weeks in order for it to heal. It was a second degree burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026276 |
| MDR Report Key | 418764 |
| Date Received | 2002-09-25 |
| Date of Report | 2002-09-25 |
| Date of Event | 2002-08-01 |
| Date Added to Maude | 2002-09-30 |
| 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 | THERMAL CARE |
| Generic Name | THERMAL CARE |
| Product Code | IMA |
| Date Received | 2002-09-25 |
| Model Number | 4841812 |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Device Expiration Date | 2004-03-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 407793 |
| Manufacturer | PROCTER & GAMBLE CO. |
| Manufacturer Address | 1 P & G CINCINNATI OH 452023315 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-09-25 |