MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-07-03 for ULTRALITE FULL BODY PHOTOTHERAPY UNIT V4472IV NA manufactured by Ultralite Enterprises, Inc.
[222233]
A pt receiving treatment by medical device received 2nd degree blistering burns. Data received by mfr indicates that treatment dosage was increased by over 300% within 8 treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045025-2001-00008 |
| MDR Report Key | 339910 |
| Report Source | 05 |
| Date Received | 2001-07-03 |
| Date of Report | 1992-02-25 |
| Date Mfgr Received | 1992-02-25 |
| Device Manufacturer Date | 1985-08-01 |
| Date Added to Maude | 2001-07-05 |
| 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 Contact | WILLIAM MCMILLAN |
| 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 | 2001-07-03 |
| Model Number | V4472IV |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 329234 |
| 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 | V4472IV |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-03 |