MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for THERMOPHORE 056 manufactured by Battle Creek Equipment.
[180777827]
Customer stated, " was using pad and smelled something funny. Took the cover off and noticed burn marks on the pad. " customer did not claim injury. Product was returned. The investigator found no evidence of burn marks. The investigator observed that the user was misusing the pad by laying on the pad. This was determined by the bent and broken leads in the pad. Ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2019-10979 |
| MDR Report Key | 9545656 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-05 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MICHAEL GREEN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOPHORE |
| Generic Name | THERMOPHORE |
| Product Code | IRT |
| Date Received | 2020-01-03 |
| Returned To Mfg | 2019-12-26 |
| Model Number | 056 |
| Lot Number | 00056033191 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BATTLE CREEK EQUIPMENT |
| Manufacturer Address | 702 S REED RD FREMONT IN 46737 US 46737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |