MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-12 for ULTRAVIOLET LIGHT FIXTURE manufactured by Guth Lighting.
[20684283]
The ultraviolet lights were on in the pt's room. The pt did not need lights on for any medical reason. As a result of the lights being on the pt suffered a "sunburn" to his skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003316 |
| MDR Report Key | 16038 |
| Date Received | 1994-09-12 |
| Date of Report | 1994-08-31 |
| Date of Event | 1994-05-19 |
| Date Added to Maude | 1994-09-13 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAVIOLET LIGHT FIXTURE |
| Generic Name | ULTRAVIOLET LIGHT FIXTURE |
| Product Code | FTC |
| Date Received | 1994-09-12 |
| ID Number | GUTH #M2911B/120PPL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15971 |
| Manufacturer | GUTH LIGHTING |
| Manufacturer Address | ST LOUIS MO 63177 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-09-12 |