MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-01-29 for LINEAR SERIES COLLIMATORS LINEAR MC150, LINEAR II, LINEAR III, LINEAR IV 70-63000, 70-43000, 70-53000, manufactured by Progeny, Inc..
[15607573]
Certain batches of collimators built in sep-oct 1999 have incorrect (shorter) screws mounting the collimator housing to the tube mounting plate. The shorter screws over time can loosen, allowing the collimator housing to sag relative to the mounting plate. If the "looseness" of the housing was not noticed by staff, the housing could eventually separate from the mounting plate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2001-00001 |
| MDR Report Key | 314486 |
| Report Source | 08 |
| Date Received | 2001-01-29 |
| Date of Report | 2001-01-25 |
| Date Mfgr Received | 2000-11-03 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2001-02-05 |
| 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 | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINEAR SERIES COLLIMATORS |
| Generic Name | COLLIMATOR |
| Product Code | KPW |
| Date Received | 2001-01-29 |
| Model Number | LINEAR MC150, LINEAR II, LINEAR III, LINEAR IV |
| Catalog Number | 70-63000, 70-43000, 70-53000, |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 304143 |
| Manufacturer | PROGENY, INC. |
| Manufacturer Address | 1407 BARCLAY BLVD. BUFFALO GROVE IL 60089 US |
| Baseline Brand Name | LINEAR SERIES COLLIMATORS |
| Baseline Generic Name | COLLIMATOR |
| Baseline Model No | LINEAR MC150, L |
| Baseline Catalog No | 70-63000, 70-43000, 70-53000, |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-01-29 |