MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-25 for BLUE LIGHT THERAPY manufactured by .
[53452157]
A reporter called on behalf of her husband, who was diagnosed with 5 types of cancers as a result of blue right therapy. According to the reporter her husband went to a dermatologist for a minor problem of skin tags. The dermatologist removed the skin tags using a freezing technique. According to the reporter the dermatologist recommended blue light therapy for her husband claiming that it prevents cancer with no long term side effects. Two years after the treatment, her husband was diagnosed with 5 types of cancers, one of them melanoma, and 4 different types of skin cancers. He has one on his face, one on his nose and 3 of them on his cheeks. The melanoma was surgically removed. She went on to say that a drug called levulan kerastick was applied as part of the therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064394 |
| MDR Report Key | 5910353 |
| Date Received | 2016-08-25 |
| Date Added to Maude | 2016-08-29 |
| 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 | 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 | 0 |
| Brand Name | BLUE LIGHT THERAPY |
| Generic Name | BLUE LIGHT THERAPY |
| Product Code | OLP |
| Date Received | 2016-08-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-25 |