MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-11 for THERMOPHORE manufactured by Battle Creek Equipment.
[182721849]
Customer stated, " there was a flash of fire on the cord near the strain relief. " customer did not claim injury. Product was returned. Investigator observed evidence of sparking at the strain relief. The pad returned was over 18 years old, making the unit beyond the life cycle of the product. The investigator determined that general wear and tear of the pad over 18 years of use caused the failures reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11077 |
| MDR Report Key | 9696211 |
| Report Source | CONSUMER |
| Date Received | 2020-02-11 |
| Date Added to Maude | 2020-02-11 |
| 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 | 2020-02-11 |
| Returned To Mfg | 2020-01-28 |
| Lot Number | 020290 |
| 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 | 2020-02-11 |