MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-11-03 for OPTIGUIDE * DCYL250 manufactured by Diomed, Inc..
[16482495]
Pt was having a photodynamic therapy of the esophagus endoscopically. Originally but ductospace was placed in a tube. Post treatment it was noticed the fiber diffuser was missing. They were not able to retrieve the piece. However it was visualized in the esophagus under flouro. A second procedure in two days revealed broken piece had passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225808-2004-00001 |
| MDR Report Key | 584990 |
| Report Source | 06 |
| Date Received | 2004-11-03 |
| Date of Report | 2004-11-03 |
| Date of Event | 2004-09-01 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2005-03-28 |
| 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 | 0 |
| Manufacturer Contact | SAMUEL WADE, DIR |
| Manufacturer Street | ONE DUNDEE PARK |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 5988241813 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIGUIDE |
| Generic Name | PDT DIFFUSER OPTICAL FIBER |
| Product Code | MVG |
| Date Received | 2004-11-03 |
| Model Number | * |
| Catalog Number | DCYL250 |
| Lot Number | 040704 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 574818 |
| Manufacturer | DIOMED, INC. |
| Manufacturer Address | * ANDOVER MA 01810 US |
| Baseline Brand Name | OPTIGUIDE |
| Baseline Generic Name | PDT DIFFUSER OPTICAL FIBER |
| Baseline Model No | * |
| Baseline Catalog No | DCYL250 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-03 |