MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-18 for HAND/FOOT II UAB-128 manufactured by National Biological Corp..
[16403]
Pt inadvertently received both uva and uvb during hand photo therapy. Uva was ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 29940 |
| MDR Report Key | 29940 |
| Date Received | 1996-01-18 |
| Date of Report | 1995-07-18 |
| Date of Event | 1995-06-21 |
| Date Facility Aware | 1995-06-22 |
| Report Date | 1995-07-05 |
| Date Reported to Mfgr | 1995-07-18 |
| Date Added to Maude | 1996-02-13 |
| 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 | 0 |
| 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 | HAND/FOOT II |
| Generic Name | PHOTO THERAPY |
| Product Code | KGL |
| Date Received | 1996-01-18 |
| Model Number | UAB-128 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31035 |
| Manufacturer | NATIONAL BIOLOGICAL CORP. |
| Manufacturer Address | 1532 ENTERPRISE PKWY TWINSBURG OH 44087 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-01-18 |