MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-14 for THERMOPHORE 055 manufactured by Battle Creek Equipment.
[183345046]
Customer stated, "was using the pad when the switch smoked. Customer sent back a letter stating they took the unit apart to conduct their own investigations and the finding they found. " customer did not claim injury. Product was returned. The investigator observed that when the product was returned that the switch was broken apart, along with components missing. Based off customers supplied letter the investigator determined that the user took apart the switch to conduct their own investigation. Additionally the investigator observed evidence of a spark within the switch housing which may have caused smoke the end user reported. The investigation was inconclusive due to the user taking apart the unit and no failure of the device could be determined. The ifu states, "never attempt to open, disassemble, or otherwise access any of the product's internal components. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11106 |
| MDR Report Key | 9712184 |
| Report Source | CONSUMER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-21 |
| Date Added to Maude | 2020-02-14 |
| 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 | 2020-02-14 |
| Returned To Mfg | 2020-01-31 |
| Model Number | 055 |
| Lot Number | 0554911 |
| 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 | 2020-02-14 |