MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-18 for BEAUTYKO EVERTONE SAUNA BELT manufactured by Unknown.
[65279281]
I was using the product daily to heat a shoulder injury (laying it open upon my shoulder). The onto it, it began to heat. Either way, this product does not have a self-shut down when it gets too hot, and there is no way that it should begin to burn and melt. There was a warning to not "bend it", although i had no idea it would self-ignite. I've had to discard my mattress and sheets and comforter, and am experiencing some stress responses to waking up in the middle of the night with my bed on fire. I have learned to unplug everything. I had another heating pad for my back in the bed, plugged in, and that product turns off when getting too hot (even though i turn them both off before sleep). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067316 |
| MDR Report Key | 6263456 |
| Date Received | 2017-01-18 |
| Date of Report | 2016-12-29 |
| Date of Event | 2016-12-09 |
| Date Added to Maude | 2017-01-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEAUTYKO EVERTONE SAUNA BELT |
| Generic Name | CABLES, SURGE & POWER PROTECTION |
| Product Code | NGX |
| Date Received | 2017-01-18 |
| Model Number | BEAUTYKO EVERTONE SAUNA BELT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-18 |