MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-10 for ULTRALITE PHOTOTHERAPY UNIT V4848NB manufactured by Ultralite Enterprises, Inc..
[16581606]
Uei became aware of an event that occurred on (b)(6) 2012, on (b)(4) 2012 by a report from medwatch. The report states a pt was undergoing a phototherapy and four days after the treatment the pt had blistering on his thighs and neck. It was decided a mdr should be filed.
Patient Sequence No: 1, Text Type: D, B5
[16604153]
Uei contacted (b)(4). (b)(6) spoke to (b)(6) and found the unit was referenced and calibrated correctly that it was a staff error. Our conversation confirmed that the machine was operating properly and no other incident had taken place.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045025-2012-00001 |
| MDR Report Key | 2869659 |
| Report Source | 05 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-12-06 |
| Date of Event | 2012-10-08 |
| Date Mfgr Received | 2012-10-31 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-12-13 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Phone | 7709630594 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRALITE PHOTOTHERAPY UNIT |
| Generic Name | ULTRALITE PHOTOTHERAPY UNIT |
| Product Code | KGL |
| Date Received | 2012-12-10 |
| Model Number | V4848NB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRALITE ENTERPRISES, INC. |
| Manufacturer Address | LAWRENCEVILLE GA 30046 US 30046 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-10 |