MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-03-19 for LINEAR III 93741 70-53000 manufactured by Progeny, Inc..
[16617007]
A technician was manipulating the x-ray tube and collimator when the collimator fell from its mounting. The technician grabbed the collimator, straining their shoulder. The patient was unhurt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2002-00001 |
| MDR Report Key | 384285 |
| Report Source | 08 |
| Date Received | 2002-03-19 |
| Date of Report | 2002-03-18 |
| Date of Event | 2001-12-04 |
| Date Mfgr Received | 2002-01-22 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 2002-03-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1407 BARCLAY BLVD |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8478503800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINEAR III |
| Generic Name | COLLIMATOR |
| Product Code | IZW |
| Date Received | 2002-03-19 |
| Model Number | 93741 |
| Catalog Number | 70-53000 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 373337 |
| Manufacturer | PROGENY, INC. |
| Manufacturer Address | 1407 BARCLAY BLVD BUFFALO GROVE IL 60089 US |
| Baseline Brand Name | EUREKA LINEAR IIIP |
| Baseline Generic Name | COLLIMATOR |
| Baseline Model No | 93741 |
| Baseline Catalog No | 70-53000-P |
| Baseline ID | NA |
| Baseline Device Family | EUREKA LINEAR COLLIMATORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K810598 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-19 |