MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-05-11 for HOUVA II PHOTOTHERAPY SYSTEM UAB-102 NA manufactured by National Biological Corp..
[15441048]
A pt had an erythemal response to an ultraviolet a (puva) treatment. Puva treatments consist of uva light treatments in conjunction with a photosensitizing agent. It was reported that the pt had taken additional medication that contained photosensitizing agents. It was also noted that pt may have doubled their dose of one of these. The response occurred 24-48 hours after treatment. The pt was hospitalized for two days and reported to also undergo some follow-up treatments. There was no misuse or malfunction of the device reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1521608-2004-00001 |
| MDR Report Key | 525150 |
| Report Source | 05 |
| Date Received | 2004-05-11 |
| Date of Report | 2004-05-11 |
| Date of Event | 2004-04-12 |
| Date Mfgr Received | 2004-04-13 |
| Device Manufacturer Date | 1991-10-01 |
| Date Added to Maude | 2004-05-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LORETTA MOONEY |
| Manufacturer Street | 1532 ENTERPRISE PARKWAY |
| Manufacturer City | TWINSBURG OH 44087 |
| Manufacturer Country | US |
| Manufacturer Postal | 44087 |
| Manufacturer Phone | 3304253535 |
| Manufacturer G1 | NATIONAL BIOLOGICAL CORP. |
| Manufacturer Street | 1532 ENTERPRISE PARKWAY |
| Manufacturer City | TWINSBURG OH 44087 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44087 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUVA II PHOTOTHERAPY SYSTEM |
| Generic Name | ULTRAVIOLET LIGHT CABINET |
| Product Code | KGL |
| Date Received | 2004-05-11 |
| Model Number | UAB-102 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 514278 |
| Manufacturer | NATIONAL BIOLOGICAL CORP. |
| Manufacturer Address | 1532 ENTERPRISE PKWY. TWINSBURG OH 44087 US |
| Baseline Brand Name | HOUVA II PHOTOTHERAPY SYSTEM |
| Baseline Generic Name | ULTRAVIOLET LIGHT CABINET |
| Baseline Model No | UAB-102 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-05-11 |