MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2006-01-19 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY 4170 manufactured by Dusa Pharmaceuticals, Inc..
[438893]
In december 2005, an installation technician was performing an install of the blu-u photodynamic therapy illuminator at a physician's office. The technician reported the following event. During the installation, the technician was holding the base unit on its side while installing the casters. The base unit reportedly "slipped" on the carpet and the technician tried to catch the unit with his right hand. The base unit landed on the technician's right hand, injurying the middle and ring fingers. The technician was treated by the physician at the office, who stitched both fingers and bandaged the hand. The technician stated he experienced pain, tingling and loss of sensation in both fingers. The technician was treated at a follow-up appointment in about two weeks later for a dressing change and reported that nurse stated his fingers "were coming along" (healing). He had another follow-up appointment scheduled in a week later to remove the stitches. As of about a week after the incident, the technician stated he was healing, however, he still felt sorness, tingling and loss of sensation in both fingers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2006-00001 |
| MDR Report Key | 667132 |
| Report Source | 00,07 |
| Date Received | 2006-01-19 |
| Date of Report | 2006-01-19 |
| Date of Event | 2005-12-15 |
| Date Mfgr Received | 2005-12-21 |
| Date Added to Maude | 2006-01-26 |
| 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 | * |
| 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 BLUE LIGHT PHOTODYNAMIC THERAPY |
| Generic Name | PHOTODYNAMIC THERAPY ILLUMINATOR |
| Product Code | MVF |
| Date Received | 2006-01-19 |
| Model Number | BLU-U |
| Catalog Number | 4170 |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 656497 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Manufacturer Address | * WILMINGTON MA * US |
| Baseline Brand Name | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY |
| Baseline Generic Name | PHOTODYNAMIC THERAPY ILLUMINATOR |
| Baseline Model No | BLU-U |
| Baseline Catalog No | 4170 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-19 |