MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for THERAM-MED BACK PAD manufactured by Carex Health Brand / Compass Health Brands (corporate Office).
[144458978]
Bad ice burn from using thera-med back pad. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086438 |
| MDR Report Key | 8590889 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-05 |
| Date of Event | 2019-05-04 |
| Date Added to Maude | 2019-05-08 |
| 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 | UNKNOWN |
| 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 | 3 |
| Brand Name | THERAM-MED BACK PAD |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2019-05-07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREX HEALTH BRAND / COMPASS HEALTH BRANDS (CORPORATE OFFICE) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |