MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-07 for THERMOPHORE 155 manufactured by Battle Creek Equipment.
[182528626]
Customer stated, "the cord was dropped and a flame shot out of it. " customer did not claim injury. Product was returned. The investigator observed a burn mark where the cord and the switch connect. Additionally, the investigator observed that the cord was twisted, and there were signs that the pad was being laid upon/folded during use. The twisting of the cord likely caused the breaking of the cord resulting in a spark. The ifu states, "loop cord loosely when storing. Tight wrapping may damage cord and internal parts. " and "do not sit on, lie on, or crush pad. Avoid sharp folds".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11070 |
| MDR Report Key | 9683329 |
| Report Source | CONSUMER |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-03 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2020-02-07 |
| Returned To Mfg | 2020-01-21 |
| Model Number | 155 |
| Lot Number | 00155123182 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-07 |