MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-07-03 for ULTRALITE FULL BODY PHOTOTHERAPY UNIT V4408 NA manufactured by Ultralite Enterprises, Inc..
[19961710]
Patient was undergoing treatment with medical device. They were using phototherapy chamber handles. Handle broke and patient fell, cutting their inner arm. Injury required 40 stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045025-2001-00007 |
| MDR Report Key | 339850 |
| Report Source | 06 |
| Date Received | 2001-07-03 |
| Date of Report | 1994-04-07 |
| Date of Event | 1994-04-06 |
| Date Mfgr Received | 1994-04-07 |
| Device Manufacturer Date | 1990-03-01 |
| 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 DERMATOLOGICAL LIGHT |
| Product Code | KGL |
| Date Received | 2001-07-03 |
| Model Number | V4408 |
| 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 | 329173 |
| 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 | V4408 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-07-03 |