MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-01 for THERMACARE * manufactured by Procter & Camble.
[362898]
Pt used a product called thermacare made by procter & gamble. Pt placed the product around their neck and then noticed about 1 hour later that their skin was burning really bad. Pt removed the pad and noticed that the necklace they were wearing slipped into the pad and acted like a heat source, which caused a second degree burn. Pt wrote a letter to the co letting them know what happened and that a product warning label needed to be added to the package, warning to remove any metal in the area to be treated. The co responed with a simple form letter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032759 |
| MDR Report Key | 548287 |
| Date Received | 2004-07-10 |
| Date of Report | 2004-07-01 |
| Date of Event | 2004-06-14 |
| Date Added to Maude | 2004-10-15 |
| 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 | 3 |
| 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 | PAIN RELIEF PATCH |
| Product Code | IMA |
| Date Received | 2004-07-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 537753 |
| Manufacturer | PROCTER & CAMBLE |
| Manufacturer Address | P.O. BOX 599 CINCINNATI OH 45202 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2004-07-10 |