MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-03 for PUVA UNK manufactured by Unk.
[217404]
Treatment given for ga with puva at med ctr. The ga was on both legs, and after an evaluation by dr, he recommended a series of puva treatments. The first treatment occurred on 4/2001 and the second treatment 3 days later. The adverse events occurred after the second treatment resulting in first, second, and third degree burns to both legs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023000 |
| MDR Report Key | 354601 |
| Date Received | 2001-10-03 |
| Date of Report | 2001-10-03 |
| Date of Event | 2001-04-27 |
| Date Added to Maude | 2001-10-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PUVA |
| Generic Name | ULTRA-VIOLET LIGHT BOOTH |
| Product Code | FTC |
| Date Received | 2001-10-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 343821 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Required No Informationntervention; 2. Deathisabilit | 2001-10-03 |