MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-06 for BLU-U PHOTODYNAMIC ILLUMINATOR 4170 * manufactured by Dusa Pharmaceuticals, Inc..
[254127]
A healthcare practitioner(physicians assistant)with a history of epilepsy,experienced a petit mal epiletic seizure 30 minutes after administration of the blu-u light treatment on a patient. The patient (administering healthcare professional)saw their physician the following day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2002-00001 |
| MDR Report Key | 382988 |
| Date Received | 2002-03-06 |
| Date of Report | 2002-03-05 |
| Date of Event | 2002-01-24 |
| Date Mfgr Received | 2002-01-24 |
| Date Added to Maude | 2002-03-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STUART MARCUS, MD, PHD |
| Manufacturer Street | 25 UPTON DR |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal | 01887 |
| Manufacturer Phone | 9147474300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLU-U PHOTODYNAMIC ILLUMINATOR |
| Generic Name | PHOTODYNAMIC ILLUMINATOR |
| Product Code | MVF |
| Date Received | 2002-03-06 |
| Model Number | 4170 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 372061 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Manufacturer Address | 25 UPTON DR. WILMINGTON MA 01887 US |
| Baseline Brand Name | BLU-U |
| Baseline Model No | 4170 |
| Baseline Catalog No | MODEL 4170 |
| Baseline Device Family | PHOTODYNAMIC ILLUMINATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9900 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-06 |