MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-05 for LIGHT RELIEF LR150 manufactured by Lightrelief, Llc.
[59393775]
Sudden death. Took bumex for 8 days as prescribed, he was a border line diabetic male and (b)(6). The medication has no warning on it for sudden death, but reviews show it causes sudden death. He was in perfect athletic condition prior to burning foot with a light device called "light relief". It is infrared light. While he was using the device, it 3rd degree burned his foot and toe, which caused in infection and retention of water in his body and death. He burned his foot with the light on (b)(6) and died on (b)(6) 2016. Dose or amount: 1 tablet, frequency: every 12 hrs, route: taken by mouth, applied to a surface, usually the skin. Event abated after use stopped or dose reduced: no. Dates of use: (b)(6) 2016. Diagnosis or reason for use: the bumex to remove retained water after burn, pain in foot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065873 |
| MDR Report Key | 6085455 |
| Date Received | 2016-11-05 |
| Date of Report | 2016-11-05 |
| Date of Event | 2016-08-14 |
| Date Added to Maude | 2016-11-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT RELIEF |
| Generic Name | LIGHT RELIEF |
| Product Code | ILY |
| Date Received | 2016-11-05 |
| Model Number | LR150 |
| Lot Number | LR150 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIGHTRELIEF, LLC |
| Manufacturer Address | LOS ANGELES CA 90010 US 90010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-11-05 |