MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-19 for LIGHT RELIEF manufactured by Light Relief.
[4125558]
Pt stated that he experienced multiple deep slow burns while using his light relief therapy for muscle pain. He described the burns as half a thumb tack size all over his back and chest. He stated that the burns were red the first day and turned black on the second day. He stated that the burns are very painful and feel as though they are deep into his muscle and bone. He also stated that he has right shoulder and arm weakness. He alleged that the device does not have adequate warning labels. He stated that he plans to see a physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033541 |
| MDR Report Key | 3532947 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-12-19 |
| Date of Event | 2013-12-08 |
| Date Added to Maude | 2013-12-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT RELIEF |
| Generic Name | INFRARED LIGHT THERAPY |
| Product Code | ILY |
| Date Received | 2013-12-19 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIGHT RELIEF |
| Manufacturer Address | VAN NUYS CA 91409 US 91409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-19 |