MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for THERMOPHORE 155 manufactured by Battle Creek Equipment.
[178228019]
Customer stated, "was using the unit between her thighs and smelled smoke. " customer did not claim injury. Product was returned. Investigator determined that the probable cause of the smoke smell was the lead wire becoming exposed causing the harness to have an exposable burn. The investigator determined this was caused by the customer misusing the product by folding/ laying on the pad while in use. Ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2019-10986 |
| MDR Report Key | 9545590 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-09 |
| Date Added to Maude | 2020-01-03 |
| 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 | 2020-01-03 |
| Returned To Mfg | 2019-12-26 |
| Model Number | 155 |
| Lot Number | 1553911 |
| 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 | 2020-01-03 |