MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-24 for THERMACARE HEATWRAP manufactured by Pfizer.
[81142174]
Patient experienced burn from thermacare back pain therapy heat wrap while using for post surgical pain relief.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071230 |
| MDR Report Key | 6743551 |
| Date Received | 2017-07-24 |
| Date of Report | 2017-07-24 |
| Date of Event | 2017-07-15 |
| Date Added to Maude | 2017-07-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 HEATWRAP |
| Generic Name | THERMACARE HEATWRAP |
| Product Code | IME |
| Date Received | 2017-07-24 |
| Lot Number | S97473 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFIZER |
| Manufacturer Address | MADISON NJ 07940 US 07940 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-24 |