MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-11 for THERMACARE manufactured by Wyeth Consumer Healthcare,.
[1956457]
I had purchased a box of thermacare menstrual relief patches and received a serious burn to my midsection. I have used this product prior to this incident with no adverse reaction. I used the restroom several times during the day and had not experienced any noticeable heat difference or irritation. However, upon my return home, i noticed a terrible pain and after removing my pants found my midsection to be seriously burnt to the point of my skin peeling. I noticed thermacare is recalling one of their products but this is a different lot number. I am in terrible pain and do not feel like this product is safe for the public. Diagnosis or reason for use: menstrual cramps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019790 |
| MDR Report Key | 2021683 |
| Date Received | 2011-03-11 |
| Date of Report | 2011-03-11 |
| Date of Event | 2011-03-11 |
| Date Added to Maude | 2011-03-22 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACARE |
| Generic Name | MENSTRUAL CRAMP RELIEF PATCH |
| Product Code | OMW |
| Date Received | 2011-03-11 |
| Lot Number | E97130 S |
| Device Expiration Date | 2013-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WYETH CONSUMER HEALTHCARE, |
| Manufacturer Address | MADISON NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-11 |