MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-06 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR 4170 * manufactured by Dusa Pharmaceuticals, Inc..
[426701]
A patient was treated for a hand wart in 2005. The levulan kerastick was applied to the wart for 30 minutes followed by approximately 8 minutes blu-u blue light photodynamic therapy illuminator light. The patient wore goggles during the treatment. The patient went home and experienced a seizure later that evening. As reported by the physician's office the patient has experienced at least one seizure previously (following a dental procedure). Patient went to the hospital after the seizure but it is unknown if they were admitted. Physician's office stated the following month that they believe the patient is recovered.
Patient Sequence No: 1, Text Type: D, B5
[434259]
A pt treated for a hand wart in 05. The levulan kerastick was applied to the wart followed 30 minutes later by approx 8 minutes of light by the blu-u blue light photodynamic therapy illuminator. The pt wore goggles during the treatment. The pt went home and experienced a seizure later that evening. The pt has experienced at least one seizure previously (following a dental procedure). Pt went to the hospital after the seizure but it is unknown if they was admitted. The pt was not admitted to the hospital following the seizure of 05. The pt has a history of seizures (at least one previously), but had been seizure free for 1 year prior to current episode. Pt is fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2005-00052 |
| MDR Report Key | 620327 |
| Report Source | 05 |
| Date Received | 2005-07-06 |
| Date of Report | 2005-06-24 |
| Date of Event | 2005-05-10 |
| Date Mfgr Received | 2005-06-10 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2005-07-13 |
| 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 | 3 |
| Manufacturer Contact | JOANNE LAVALLE |
| Manufacturer Street | 25 UPTON DRIVE |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal | 01887 |
| Manufacturer Phone | 9786577500 |
| Manufacturer G1 | DUSA PHARMACEUTICALS, INC. |
| Manufacturer Street | 25 UPTON DRIVE |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
| Generic Name | LIGHT, PHOTODYNAMIC |
| Product Code | MVF |
| Date Received | 2005-07-06 |
| Model Number | 4170 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 610015 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Manufacturer Address | * WILMINGTON MA * 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. Life Threatening; 2. Other | 2005-07-06 |