MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-09 for ULTRAVIOLET IRRADIATOR manufactured by Foundation For Blood Irradiation.
[26828]
There is no 510k submission even if the mfr claims there is. Mfr's advertisment implies "it is fda certified for use in the us" but it has not been approved by the fda. The device has safety problems with irradiating blood. One of the safety problems is damage to the dna. The device is significantly different from the old device on the market. This technical difference makes it unsafe. The product labeling makes claimes that cannot be proven. Pt is usually hooked to the administration set and blood flows through the device and than goes to the bottle and it is pumped back to the pt. Therefore, being exposed to ultraviolet light source.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009070 |
| MDR Report Key | 32931 |
| Date Received | 1996-05-09 |
| Date of Report | 1996-05-09 |
| Date Added to Maude | 1996-05-16 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | ULTRAVIOLET IRRADIATOR |
| Generic Name | ULTRAVIOLET BLOOD IRRADIATION DEVICE |
| Product Code | MOT |
| Date Received | 1996-05-09 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34230 |
| Manufacturer | FOUNDATION FOR BLOOD IRRADIATION |
| Manufacturer Address | 1350 APPLE AVE SILVER SPRING MD 20910 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-09 |