MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-21 for CRITERION PDT LASER * manufactured by Criterion.
[524468]
Pt scheduled for pdt (photo dynamic therapy) using laser, for esophageal cancer treatment. Laser device is new, not used before, was checked the evening prior to this procedure and check was performed without problems. Day of procedure, pt was anesthetized and esophageal scope placed, biopsies done, when attempted to use the laser, the device would not work. Procedure was aborted and pt admitted for procedure the next day. Sales rep called in, new laser brought and the procedure went well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037572 |
| MDR Report Key | 746932 |
| Date Received | 2005-11-21 |
| Date of Report | 2005-11-21 |
| Date of Event | 2005-11-15 |
| Date Added to Maude | 2006-08-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRITERION PDT LASER |
| Generic Name | PHOTO DYNAMIC THERAPY LASER |
| Product Code | MVF |
| Date Received | 2005-11-21 |
| Returned To Mfg | 2005-11-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734723 |
| Manufacturer | CRITERION |
| Manufacturer Address | 3189 JENNETTE AVE PARKS CITY IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-11-21 |