MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-23 for HOUVA III UHU-317 * manufactured by National Biological Corporation.
[18933731]
Reportedly, three patients undergoing phototherapy treatment were found to have sunburn at their follow-up appointments. They did not require treatment. The phototherapy booth was closed and underwent full maintenance including replacement of the sensors and uvb lamps. The phototherapy booth was re-opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4673607 |
| MDR Report Key | 4673607 |
| Date Received | 2015-03-23 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-02-16 |
| Report Date | 2015-03-23 |
| Date Reported to FDA | 2015-03-23 |
| Date Reported to Mfgr | 2015-04-09 |
| Date Added to Maude | 2015-04-09 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUVA III |
| Generic Name | LIGHT, ULTRAVIOLET, DERMATOLOGICAL |
| Product Code | FTC |
| Date Received | 2015-03-23 |
| Model Number | UHU-317 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 14 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL BIOLOGICAL CORPORATION |
| Manufacturer Address | 23700 MERCANTILE RD. BEACHWOOD OH 44122 US 44122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-23 |