MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-02 for LINGAR COLLIMATOR * manufactured by Progeny, Inc.
[694512]
Screw loose in the radiation field leaving artifact on images. Service called. Device checked and cleaned. Could not find where screw came from in housing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 889514 |
| MDR Report Key | 889514 |
| Date Received | 2007-07-02 |
| Date of Report | 2007-07-02 |
| Date of Event | 2007-06-25 |
| Report Date | 2007-07-02 |
| Date Reported to FDA | 2007-07-02 |
| Date Added to Maude | 2007-08-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | LINGAR COLLIMATOR |
| Generic Name | X-RAY SYSTEM COLLIMATOR |
| Product Code | IZW |
| Date Received | 2007-07-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 70-75002 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 867195 |
| Manufacturer | PROGENY, INC |
| Manufacturer Address | 1407 BARCLAY BLVD BUFFALO GROVE IL 60089 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-02 |