MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-05 for THERMOPHORE 155 manufactured by Battle Creek Equipment.
[182722945]
Customer stated, "smelled an electrical burning odor. She looked down and saw a spark come from the cord. She puts the pad on the wedge and lays back on it. Sometimes she lays flat on the floor on the pad. Sometimes she wraps the pad around her lower leg" customer did not claim injury. Product was returned. The investigator observed a burn mark on the cord at the butterfly. The investigator determined the burn was caused by the insulation of the wires being wore down, due to excessive flexing of the cord. The investigator observed evidence to corroborate the users statement of misuse of laying on and wrapping the pad while in use. The ifu states, never wrap, hold, or loop the cord in any position which sharply bends it. Ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11042 |
| MDR Report Key | 9673696 |
| Report Source | CONSUMER |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-07 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| Returned To Mfg | 2020-01-16 |
| Model Number | 155 |
| Lot Number | 00155016195 |
| 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 | 2020-02-05 |