MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-24 for THERMOPHORE 055 manufactured by Battle Creek Equipment.
[181212527]
Customer stated, "she lays the pad down and lays down on the pad. She was laying down holding the switch down and she looked down and saw flames coming out of the switch area. " customer did not claim injury. Product was not returned. An investigation into the lot found no instances of reported issues for the manufactured lot. An investigation into similar feedbacks found that the primary cause for the similar feedbacks was user misuse due to cord twisting/wrapping. The ifu states, "loop cord loosely when storing. Tight wrapping may damage cord and internal parts". The customer also admitted to misusing the pad by laying on it. The ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds". Further investigation will be conducted once the product is returned, along with a supplemental report submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2019-11026 |
| MDR Report Key | 9629847 |
| Report Source | CONSUMER |
| Date Received | 2020-01-24 |
| Date of Report | 2019-12-30 |
| Date Added to Maude | 2020-01-24 |
| 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 | 2020-01-24 |
| Model Number | 055 |
| Lot Number | 0552212 |
| 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 46737 US 46737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |