MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-14 for HOUVA III UHU-318 manufactured by National Biological Corp..
[5375701]
The pt received treatment on (b)(6) 2014 for approximately 8 minutes and 4 seconds at 2000 mj. The pt was wearing nbc provided goggles (part # 9pe-004), as well as a pillow case over her head. Prior to the start of the treatment the nurse instructed the pt to put on her goggles. The pillow case was then placed over her head. The nurse verified the pt was wearing her goggles and the pillow case when the treatment started before she exited the room. On (b)(6) 2014 the pt awoke at 2 am and complained of a burning sensation on her eyes. The pt's mother took the pt to the emergency room where they referred her to a ophthalmologist. The pt saw the ophthalmologist and was treated for corneal burns. The pt's mother called uconn dermatology association on (b)(6) 2014 and stated that the pt was burned during her last treatment on (b)(6) 2014. The pt's goggles were checked and were found to be 100% uv blocking and free from damage and defect. The pillow case used was checked and found to be free from damage or defect. The output of the phototherapy device was checked and was reported at 4. 13 which falls within the normal output range of 1. 80- 7. 40.
Patient Sequence No: 1, Text Type: D, B5
[12758113]
National biological corporation's filed service technician evaluated the phototherapy device in question on (b)(6) 2014. The standard national biological corporation installation and service protocol was followed. Per the field service technician's installation and in-service summary report the "booth is in 100% working order. Sensor and meter calibrations are up to date. Line/load voltage is normal. Timer profile reading is accurate. Goggles are nbc and are 100% uvb blocking per 500c meter # (b)(4) and (b)(4) rm. No indication of damage or defect to the goggles". During the national biological corporation complaint intake process it was noted that the pt stated that they did not remove their goggles during the treatment on (b)(6) 2014. When national biological corporation contacted uconn dermatology association the nurse disclosed that in the past, and on separate occasions, the pt has removed the pillow case and goggles and peeked during treatments; and has come out of the unit during treatment and tried to restart the phototherapy device herself. Due to the fact that the field service technician's report concluded that the phototherapy device and goggles in question were found to be operating within specifications nbc believes the pt injury was clearly a result of misuse of instructions for use a it pertains to eye protection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1521608-2014-00001 |
| MDR Report Key | 4425601 |
| Report Source | 06 |
| Date Received | 2015-01-14 |
| Date of Report | 2014-01-07 |
| Date of Event | 2014-12-09 |
| Date Mfgr Received | 2014-12-11 |
| Device Manufacturer Date | 2009-03-06 |
| Date Added to Maude | 2015-01-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 23700 MERCANTILE ROAD |
| Manufacturer City | BEACHWOOD OH 44122 |
| Manufacturer Country | US |
| Manufacturer Postal | 44122 |
| Manufacturer Phone | 2168310600 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUVA III |
| Generic Name | PHOTOTHERAPY UNIT |
| Product Code | KGL |
| Date Received | 2015-01-14 |
| Model Number | UHU-318 |
| Catalog Number | UHU-318 |
| Lot Number | 6986 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL BIOLOGICAL CORP. |
| Manufacturer Address | 23700 MERCANTILE ROAD BEACHWOOD OH 44122 US 44122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-14 |