MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for THERMACARE HEATWRAP ADVANCED BACK PAIN THERAPY, L/XL manufactured by Pfizer Inc..
[128731320]
Used thermacare back pain therapy heat wrap for 6 hrs as directed, experienced sunburn and rash like side effects the next day. How was it used or taken? Topical. Therapy duration: 6 hour. Reason for use: back pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081643 |
| MDR Report Key | 8110592 |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-11-25 |
| Date Added to Maude | 2018-11-28 |
| 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 |
| 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 ADVANCED BACK PAIN THERAPY, L/XL |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2018-11-27 |
| Lot Number | W91247 |
| 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 | 2018-11-27 |