MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-22 for THERMOPHORE 155 manufactured by Battle Creek Equipment.
[180774890]
Customer stated, " the pad caught fire by the wires leading into the switch. " customer did not claim injury. Product was not returned. An investigation into the manufactured lot found no other instances of potential fires occurring from this lot. An investigation into returned products for pad fire found that fire was primarily caused by customer misuse of twisting/ wrapping the cord to tight or folding/ laying on the pad. The ifu states, "loop cord loosely when storing. Tight wrapping may damage cord and internal parts. ", "do not sit on, lie on, or crush pad. Avoid sharp folds". Further investigation will be conducted once the product is returned, along with a supplemental report submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2019-11020 |
| MDR Report Key | 9616554 |
| Report Source | CONSUMER |
| Date Received | 2020-01-22 |
| Date of Report | 2019-12-23 |
| Date Added to Maude | 2020-01-22 |
| 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 | 2020-01-22 |
| Model Number | 155 |
| Lot Number | 0155065195 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-22 |