MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-06-01 for ULTRALITE 6809 FULL BODY PHOTOTHERAPY UNIT V4472IV NA manufactured by Ultralite Enterprises, Inc.
[16276805]
Ultraviolet dermatological lamp chamber weas cleaned by a maintenance technician. Ultraviolet a & b bulbs were removed for cleaning. When bulbs were replaced they were not put in the correct slots, thus pt's were subjected to incorrect phototherapy dosages. Four pts received 1st degree burns before the mixup was discovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045025-2001-00003 |
| MDR Report Key | 336241 |
| Report Source | 05,06 |
| Date Received | 2001-06-01 |
| Date of Event | 1995-04-24 |
| Device Manufacturer Date | 1983-12-01 |
| Date Added to Maude | 2001-06-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 390 FARMER COURT |
| Manufacturer City | LAWRENCEVILLE GA 30045 |
| Manufacturer Country | US |
| Manufacturer Postal | 30045 |
| Manufacturer Phone | 7709630594 |
| 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 6809 FULL BODY PHOTOTHERAPY UNIT |
| Generic Name | ULTRAVIOLET DERMATOLOGICAL LIGHT |
| Product Code | KGL |
| Date Received | 2001-06-01 |
| Model Number | V4472IV |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 325552 |
| Manufacturer | ULTRALITE ENTERPRISES, INC |
| Manufacturer Address | 390 FARMER CT. LAWRENCEVILLE GA 30045 US |
| Baseline Brand Name | ULTRALITE FULL BODY PHOTOTHERAPY UNIT |
| Baseline Generic Name | ULTRAVIOLET DERMATOLOGICAL LIGHT |
| Baseline Model No | V4472IV |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-06-01 |