MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-04-14 for FLOOR MOUNTED TUBE STAND FMTS 110-0065G1 manufactured by Del Medical Imaging.
[15189428]
Tube and collimator fell from tube stand.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1418964-2004-00001 |
MDR Report Key | 550664 |
Report Source | 08 |
Date Received | 2004-04-14 |
Date of Report | 2004-04-02 |
Date Mfgr Received | 2004-04-02 |
Device Manufacturer Date | 2000-02-01 |
Date Added to Maude | 2004-10-25 |
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 | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | VERONICA MERIDITH |
Manufacturer Street | 11550 W. KING STREET |
Manufacturer City | FRANKLIN PARK IL 60131 |
Manufacturer Country | US |
Manufacturer Postal | 60131 |
Manufacturer Phone | 8472887000 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | RP |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | FLOOR MOUNTED TUBE STAND |
Generic Name | TUBE STAND |
Product Code | IYB |
Date Received | 2004-04-14 |
Returned To Mfg | 2004-04-12 |
Model Number | FMTS |
Catalog Number | 110-0065G1 |
Lot Number | FEB2000 |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 540180 |
Manufacturer | DEL MEDICAL IMAGING |
Manufacturer Address | * FRANKLIN PARK IL 60131 US |
Baseline Brand Name | FLOOR MOUNTED TUBE STAND |
Baseline Generic Name | TUBE STAND |
Baseline Model No | FMTS |
Baseline Catalog No | 110-0065G1 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2004-04-14 |