MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-12 for THERMOPHORE 156 manufactured by Battle Creek Equipment.
[182929673]
Customer stated "the light comes on but there is no heat. " customer did not claim injury. Product was returned. The investigator observed a burn mark on the inside of the unit by the butterfly. The investigator determined twisting of the wires connecting the cord to the pad caused a break in the cord, which lead to the burn mark. This is a manufactures defect. After further investigation, no additional product was impacted and no additional actions were required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11071 |
| MDR Report Key | 9702515 |
| Report Source | CONSUMER |
| Date Received | 2020-02-12 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| Returned To Mfg | 2020-01-16 |
| Model Number | 156 |
| Lot Number | 00156310181 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |