FLOOR MOUNTED TUBE STAND FMTS 110-0065G1

MAUDE Adverse Event Report

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.

Event Text Entries

[15189428] Tube and collimator fell from tube stand.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1418964-2004-00001
MDR Report Key550664
Report Source08
Date Received2004-04-14
Date of Report2004-04-02
Date Mfgr Received2004-04-02
Device Manufacturer Date2000-02-01
Date Added to Maude2004-10-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactVERONICA MERIDITH
Manufacturer Street11550 W. KING STREET
Manufacturer CityFRANKLIN PARK IL 60131
Manufacturer CountryUS
Manufacturer Postal60131
Manufacturer Phone8472887000
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRP
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameFLOOR MOUNTED TUBE STAND
Generic NameTUBE STAND
Product CodeIYB
Date Received2004-04-14
Returned To Mfg2004-04-12
Model NumberFMTS
Catalog Number110-0065G1
Lot NumberFEB2000
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key540180
ManufacturerDEL MEDICAL IMAGING
Manufacturer Address* FRANKLIN PARK IL 60131 US
Baseline Brand NameFLOOR MOUNTED TUBE STAND
Baseline Generic NameTUBE STAND
Baseline Model NoFMTS
Baseline Catalog No110-0065G1
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2004-04-14

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