MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for THERMACARE HEAT WRAP manufactured by Pfizer Inc..
[122312590]
Pt was in active labor with lower back pain. Thermacare head pad was applied per packaging instruction over the gown below the site of epidural insertion area. Upon removal of epidural tape, a burn wound was discovered with dimensions 4cm by 5cm. Lower back pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080209 |
| MDR Report Key | 7922300 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-14 |
| Date Added to Maude | 2018-10-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| 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 HEAT WRAP |
| Generic Name | PACK, HOT OR COLD REUSABLE |
| Product Code | IME |
| Date Received | 2018-09-28 |
| Lot Number | T98298 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFIZER INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-28 |