MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-31 for THERMOPHORE 156 manufactured by Battle Creek Equipment.
[182366280]
Customer stated, "the unit sparked. " customer did not claim injury. Product was returned. The investigator observed a break in the cord. The investigator determined that this break caused the spark reported by the customer. The investigator determined the break in the cord was caused by the standard use of the product over 10 years. The manufactures life of the product is 4 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11031 |
| MDR Report Key | 9656037 |
| Report Source | CONSUMER |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-02 |
| Date Added to Maude | 2020-01-31 |
| 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 | 2020-01-31 |
| Returned To Mfg | 2020-01-08 |
| Model Number | 156 |
| Lot Number | 156-4210 |
| 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 | 2020-01-31 |