MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-04-08 for ULTRALITE FULL BODY PHOTOTHERAPY UNIT NOT REPORTED manufactured by Ultralite Enterprises, Inc..
[364033]
Ultralite enterprises, inc. Became aware of an event that occurred in 1/2003, through correspondence from an attorney. The attorney states his client received burns. At a university phototherapy dept. Using ultralite equipment. No model number, serial number or further info was given. It was decided that an mdr should be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045025-2004-00001 |
| MDR Report Key | 520342 |
| Report Source | 00 |
| Date Received | 2004-04-08 |
| Date of Report | 2004-04-02 |
| Date of Event | 2003-01-21 |
| Date Mfgr Received | 2004-02-19 |
| Date Added to Maude | 2004-04-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | 9630594 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRALITE FULL BODY PHOTOTHERAPY UNIT |
| Generic Name | UV DERMATOLOGY LIGHT |
| Product Code | KGL |
| Date Received | 2004-04-08 |
| Model Number | NOT REPORTED |
| Catalog Number | NOT REPORTED |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 509438 |
| Manufacturer | ULTRALITE ENTERPRISES, INC. |
| Manufacturer Address | 390 FARMER COURT LAWRENCEVILLE GA 30045 US |
| Baseline Brand Name | ULTRALITE FULL BODY PHOTOTHERAPY UNIT |
| Baseline Generic Name | UV DERMATOLOGY LIGHT |
| Baseline Model No | NOT REPORTED |
| Baseline Catalog No | NOT REPORTED |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2004-04-08 |