MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-11-08 for EUREKA LINEAR III 70-50000 manufactured by Progeny, Inc..
[19495483]
Collimator fell from tubestand during a tomographic examination, striking the pt in the face. Lacerations required stitches for treatment. Hosp reported threaded hole in mounting collar to be stripped. Product has not been made available to mfr for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2000-00001 |
| MDR Report Key | 304031 |
| Report Source | 00 |
| Date Received | 2000-11-08 |
| Date of Report | 2000-11-07 |
| Date of Event | 2000-10-17 |
| Date Mfgr Received | 2000-10-19 |
| Device Manufacturer Date | 1998-03-01 |
| Date Added to Maude | 2000-11-14 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EUREKA LINEAR III |
| Generic Name | COLLIMATOR |
| Product Code | IZW |
| Date Received | 2000-11-08 |
| Model Number | LINEAR III |
| Catalog Number | 70-50000 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 294236 |
| Manufacturer | PROGENY, INC. |
| Manufacturer Address | 1407 BARCLAY BLVD. BUFFALO GROVE IL 60089 US |
| Baseline Brand Name | LINEAR III |
| Baseline Generic Name | COLLIMATOR |
| Baseline Model No | LINEAR III |
| Baseline Catalog No | 70-5XXXX |
| Baseline Device Family | LINEAR COLLIMATORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K821133 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-11-08 |