MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-21 for DCYL 250 630PDT * manufactured by Diomed Axcan.
[21616041]
Laser tip embedded into pt's esophagus and broke off during photo dynamic therapy. Pt returned 2 days later for second pdt and tip was found to be in pt's stomach. Pt should be able to pass without incident. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033592 |
| MDR Report Key | 555014 |
| Date Received | 2004-09-21 |
| Date of Report | 2004-09-14 |
| Date of Event | 2004-09-01 |
| Date Added to Maude | 2004-11-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DCYL 250 |
| Generic Name | CYLINDRICAL DIFFISER 5.0CM |
| Product Code | MVG |
| Date Received | 2004-09-21 |
| Model Number | 630PDT |
| Catalog Number | * |
| Lot Number | 040704 |
| ID Number | * |
| Device Expiration Date | 2006-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 544650 |
| Manufacturer | DIOMED AXCAN |
| Manufacturer Address | ONE DUNDEE PARK, SUITE 5 ANDOVER MA 01810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-21 |