MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-31 for ULTRALITE 680S PHOTOTHERAPY UNIT V48NE manufactured by Ultralite Enterprises Inc..
[17127010]
This is a pt who was undergoing phototherapy treatment. Four days after this treatment, the pt reported blistering on his thighs and neck. The exposed area was treated with topical ointments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027456 |
| MDR Report Key | 2820965 |
| Date Received | 2012-10-31 |
| Date of Report | 2012-10-31 |
| Date of Event | 2012-10-28 |
| Date Added to Maude | 2012-11-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRALITE 680S PHOTOTHERAPY UNIT |
| Generic Name | ULTRALITE PHOTOTHERAPY UNIT |
| Product Code | KGL |
| Date Received | 2012-10-31 |
| Model Number | V48NE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRALITE ENTERPRISES INC. |
| Manufacturer Address | LAWRENCEVILLE GA 30045 US 30045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-31 |