MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-02 for THERMACARE HEATWRAPS * manufactured by Wyeth Consumer Healthcare.
[20742001]
On (b)(6), 2010, i used thermacare heatwraps menstrual lot number e06831s. When i removed the wrap, i noticed that i had two quarter sized red patches where the patch had touched my lower abdomen. The two patches began itching and the skin bubbled up. I believe both patches were third degree burns. I had to treat the areas for about a month. I now have two scars where the burns occurred. Used 6 hours for menstrual cramps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019269 |
| MDR Report Key | 1981142 |
| Date Received | 2011-02-02 |
| Date of Report | 2011-02-02 |
| Date of Event | 2010-11-20 |
| Date Added to Maude | 2011-02-08 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACARE HEATWRAPS |
| Generic Name | MENSTRUAL CRAMP HEATWRAPS |
| Product Code | OMW |
| Date Received | 2011-02-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | E06831S |
| ID Number | * |
| Device Expiration Date | 2012-12-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WYETH CONSUMER HEALTHCARE |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-02-02 |