MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-04-20 for THERMACARE HEATWRAPS, MENSTRUAL(NOT APPLICABLE) WRAP 1APPLIC manufactured by Wyeth Consumer Healthcare.
[20196407]
Burnt fat cells [thermal burn]. Red skin [erythema]. Fat corrocious [unevaluable event]. I use this on a constant basis, like all the time [device misuse]. Case description: the patient is a (b) (6) female who used a thermacare menstrual heatwrap transdermally for the treatment of menstrual cramps on (b) (6) 2009. The patient experienced "burnt fat cells" below the skin that would require plastic surgery to repair. Medical history included severe menstrual problems. Concomitant medications were not provided. On (b) (6) 2009, the patient began using thermacare menstrual heatwraps. The patient reported removing the heatwrap after an unspecified length of time and her skin was red. The redness did not improve and the patient continued using the wrap everyday. A few days later (and "i use this on a constant basis, like all the time") she went to the doctor. The physician stated that she had "fat corrocious" which is burnt fat cells below the skin and can only be totally corrected through plastic surgery. Treatment was not provided and the patient has not recovered. Burn ((b) (4)). Redness ((b) (4)). Unevaluable event ((b) (4)). Device misuse ((b) (4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066015-2009-00002 |
| MDR Report Key | 1367833 |
| Report Source | 04 |
| Date Received | 2009-04-20 |
| Date of Report | 2009-03-23 |
| Date of Event | 2009-02-10 |
| Date Mfgr Received | 2009-03-23 |
| Date Added to Maude | 2010-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JILL ROBINSON |
| Manufacturer Street | P.O. BOX 7667 |
| Manufacturer City | PHILADELPHIA PA 191017667 |
| Manufacturer Country | US |
| Manufacturer Postal | 191017667 |
| Manufacturer Phone | 4848656841 |
| Manufacturer G1 | WYETH CONSUMER HEALTHCARE |
| Manufacturer Street | 1231 WYANDOTTE DRIVE |
| Manufacturer City | ALBANY GA 31705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 31705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACARE HEATWRAPS, MENSTRUAL(NOT APPLICABLE) WRAP 1APPLIC |
| Generic Name | DISPOSABLE PACK, HOT |
| Product Code | OMW |
| Date Received | 2009-04-20 |
| Lot Number | 8289U018N |
| Device Expiration Date | 2011-09-01 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WYETH CONSUMER HEALTHCARE |
| Manufacturer Address | ALBANY GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-04-20 |