MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,05,06 report with the FDA on 2001-08-31 for ULTRALITE FULL BODY PHOTOTHERAPY UNIT V4408 NA manufactured by Ultralite Enterprises, Inc..
[231481]
Uei 1st report of injury, in 2001 from pt's spouse. Pt's spouse states,pt burned twice by unit. Uei called facility. Supervisor at facility stated, uei was not called because pt was not burned greater than a sunburn, and in 2001 was 1st treatment and sunburns are common side affect of treatment. Nsg. Supervisor also stated that pt going to tanning salon in between treatments. Nsg. Supervisor also stated pt went to hospital after 4/2001 because family insisted. (pt on dialysis ).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045025-2001-00009 |
| MDR Report Key | 357393 |
| Report Source | 00,04,05,06 |
| Date Received | 2001-08-31 |
| Date of Report | 2001-08-29 |
| Date of Event | 2001-04-01 |
| Date Mfgr Received | 2001-08-10 |
| Device Manufacturer Date | 1993-12-01 |
| Date Added to Maude | 2001-10-25 |
| 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 FULL BODY PHOTOTHERAPY UNIT |
| Generic Name | ULTRAVIOLET DERMATOLOGY LIGHT |
| Product Code | KGL |
| Date Received | 2001-08-31 |
| Model Number | V4408 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 346614 |
| Manufacturer | ULTRALITE ENTERPRISES, INC. |
| Manufacturer Address | 390 FARMER COURT LAWRENCEVILLE GA 30045 US |
| Baseline Brand Name | ULTRALITE FULL BODY PHOTOTHERAPY UNIT |
| Baseline Generic Name | ULTRAVIOLET DERMATOLOGICAL LIGHT |
| Baseline Model No | V4408 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-31 |