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 155 manufactured by Battle Creek Equipment.
[180777757]
Customer stated, "pad will not shut off. " customer did not claim injury. Product was returned. Investigator determined through testing that the switch when put in the off position would still return to drawing power as if on the high setting. Further investigation will be conducted by switch manufacturer, along with a follow up report submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2019-10983 |
| MDR Report Key | 9545665 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-06 |
| 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 | 2019-12-16 |
| Model Number | 155 |
| Lot Number | 00155037193 |
| 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 |