MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-07-22 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR 4170-3 manufactured by Dusa Pharmaceuticals, Inc..
[337986]
A co employee was installing a blu-u blue light photodynamic therapy illuminator unit in a physician's office in 2004. They positioned the carton containing the base unit of the device on its side in order to open the shipping container box. Upon opening the shipping box, the base unit fell over and landed on the employee's hand, severing their fingertip of the left middle finger. The fingertip was severed underneath the fingernail before the junction of the knuckle. Emergency personnel took pt to an er where the tip was sutured and reattached to the rest of the digit. They were treated with oral cephalexin 500mg, 4 times per day, for infection prophylaxis and hydrocodone w/apap for pain as needed. Reported that between 6/04 and 07/04, they were evaluated and treated by a plastic surgeon with a erchonia low level laser device for a total of 6 visits for a "black and purple finger with gangrene. " pt reported as of 7/04, the skin was described as being pink with blood around the suture and no signs of gangrene. The stitches were removed nineteen days later and some dead skin was removed from the tip of the finger. Two days afterwards the employee continues to heal and have weekly medical evaluations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2004-00001 |
| MDR Report Key | 535974 |
| Report Source | 07 |
| Date Received | 2004-07-22 |
| Date of Report | 2004-07-22 |
| Date of Event | 2004-06-24 |
| Date Mfgr Received | 2004-06-25 |
| Device Manufacturer Date | 2001-04-01 |
| Date Added to Maude | 2004-07-27 |
| 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 | * |
| 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 ILLUMINATOR |
| Generic Name | BLUE LIGHT THERAPY DEVICE |
| Product Code | MVF |
| Date Received | 2004-07-22 |
| Model Number | 4170-3 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 525223 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Manufacturer Address | * WILMINGTON MA * US |
| Baseline Brand Name | BLU-U BLUE PHTODYNAMIC THERAPY ILLUMINATOR |
| Baseline Generic Name | BLUE LIGHT THERAPY DEVICE |
| Baseline Model No | 4170-3 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-07-22 |