MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-11 for THERMOPHORE 155 manufactured by Battle Creek Equipment.
[183135026]
Customer stated, "after midnight laying in bed, he woke up to sparks and flames shooting out from the switch. Every time he touched the switch he got shocked. The switch was glowing red and never shut off. " customer claimed injury. Product was returned. The investigator observed that the pad was bunched and that the cord was wrapped and twisted. The severity of the twisting of the cord is the probable cause of the cut on the cord near the switch. The investigator determined that the cut on the cord exposed a wire which would corroborate the customer report of getting shocked, seeing sparks and/or flames "shooting out of the switch". The root cause of the issue was determined to be customer misuse of twisting and wrapping the cord. The ifu states, "loop cord loosely when storing. Tight wrapping may damage cord and internal parts. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11171 |
| MDR Report Key | 9818288 |
| Report Source | CONSUMER |
| Date Received | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-03-11 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 155 |
| Lot Number | 000155258173 |
| 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 | 2020-03-11 |