MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-18 for THERMOPHORE manufactured by Battle Creek Equipment.
[186126468]
Customer stated, "flames of fire shot out of the switch. " customer did not claim injury. Product was not returned. The product reported of having an issue is approximately 63 years old. The confirmation of the failure could not be confirmed, as the product was not received. The age of the device is the likely cause of any failures. Once product is received and investigated a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11223 |
| MDR Report Key | 9850766 |
| Report Source | CONSUMER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-24 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| Lot Number | 003040 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |