MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-04-02 for ULTRALITE FULL BODY PHOTOTHERAPY UNIT V4824TL manufactured by Ultralite Enterprises Inc..
[16276844]
A new clinical staff member keyed in a 13 minute treatment instead of 1 minute 30 seconds specified for a uvb treatment. Treatment was shopped after approximately 5 minutes. Event was caused by operator error. Last week dr began uvb treatments on pt. Uvb time for first treatment was 1 minute. In 2002, during second treatment, a new clinical staff member was to advance the time to 1. 30 minutes. Instead, staff member keyed 13 minutes. Staff member asked another staff member to check what staff member had keyed and the second more experienced employee, immediately stopped the puva machine at a little over 5 minutes. The patient was questioned and reported they were fine. The patient was seen again today and presented with 2nd degree burns. Dr spoke at length with the patient and reporter did a follow-up telephone call. Pt understands this was an operator error. Reporter will be talking with this patient again on monday to see how they are doing. Pt also has another appt with dr next thursday.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045025-2002-00001 |
| MDR Report Key | 386331 |
| Report Source | 05 |
| Date Received | 2002-04-02 |
| Date of Report | 2002-04-01 |
| Date of Event | 2002-03-21 |
| Date Mfgr Received | 2002-03-21 |
| Device Manufacturer Date | 2001-02-01 |
| Date Added to Maude | 2002-04-08 |
| 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 FULL BODY PHOTOTHERAPY UNIT |
| Generic Name | UV DERMATOLOGY LIGHT |
| Product Code | KGL |
| Date Received | 2002-04-02 |
| Model Number | V4824TL |
| Catalog Number | V4824TL |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 375343 |
| 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 | V4824TL |
| Baseline Catalog No | V4824TL |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-02 |