MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-18 for UV LIGHT manufactured by .
[3742085]
The reporter has scleroderma disease ( a disease in which the skin becomes progressively hard and thickened). She met with one dr (b)(6), who recommends a narrow band uv light therapy. During treatment she was exposed to the uv light, she now has burns all over her body, she believe is she stayed under the light longer than she was supposed to. After five sessions of the treatment she developed severe contracture on skin, upper and lower arms, and chest, also blisters all over her arms. Her condition got worst than she was before the treatment. She was given a steroid ointment (triamcinolone) and percocet for pain. She refuses to go back to the doctor as he is not helping and she does not know the manufacturer of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031903 |
| MDR Report Key | 3360439 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-09-18 |
| Date of Event | 2013-07-23 |
| Date Added to Maude | 2013-09-23 |
| 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 | UV LIGHT |
| Generic Name | UV LIGHT |
| Product Code | MXG |
| Date Received | 2013-09-18 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-18 |