MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-20 for HOUVA-LIFE COMBINATION UNIT manufactured by National Biological Corp..
[16348]
Timer on unit malfunctioned and did not shut off at the specified time. Pt received first and second degree burns and photo radiation induced cellulitis. Pt was admitted to hosp burn unit. Mfr was notified and repairman confirmed timer was malfunctioning on 10/23/95. Timer was replaced on 10/30/95.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007968 |
| MDR Report Key | 28914 |
| Date Received | 1995-12-20 |
| Date of Report | 1995-12-08 |
| Date of Event | 1995-10-02 |
| Date Added to Maude | 1995-12-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUVA-LIFE COMBINATION UNIT |
| Generic Name | PHOTOTHERAPY UNIT |
| Product Code | KGL |
| Date Received | 1995-12-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29890 |
| Manufacturer | NATIONAL BIOLOGICAL CORP. |
| Manufacturer Address | 1532 ENTERPRISE PKWY TWINSBURG OH 44087 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-12-20 |