MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for THERMACARE HEATWRAPS manufactured by Pfizer Inc..
[129306973]
Was burned by thermacare heatwraps for menstrual pain. Had an open wound the size/shape of a heat cell on the right side of my abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081759 |
| MDR Report Key | 8124634 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-14 |
| Date Added to Maude | 2018-12-03 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMACARE HEATWRAPS |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2018-11-30 |
| Lot Number | W36662 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFIZER INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-30 |