TRAUMEX 100-01-002 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-07 for TRAUMEX 100-01-002 * manufactured by Fischer Imaging Corp..

Event Text Entries

[244522] The automatic cassette loader fell off the traumex.
Patient Sequence No: 1, Text Type: D, B5

[19549807] The automatic cassette loader fell off the traumex.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number1418957-2001-00006
MDR Report Key338528
Date Received2001-06-07
Date of Report2001-06-01
Date Mfgr Received2001-01-12
Date Added to Maude2001-06-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactSAMIR PALIWAL
Manufacturer Street12300 N. GRANT DRIVE
Manufacturer CityDENVER CO 80241
Manufacturer CountryUS
Manufacturer Postal80241
Manufacturer Phone3034526800
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRAUMEX
Generic NameRADIOGRAPHIC SYSTEM
Product CodeITY
Date Received2001-06-07
Model Number100-01-002
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key327832
ManufacturerFISCHER IMAGING CORP.
Manufacturer Address12300 NORTH GRANT DRIVE DENVER CO 80241 US
Baseline Brand NameTRAUMEX
Baseline Generic NameRADIOGRAPHIC SYSTEM
Baseline Model No100-01-002
Baseline Catalog No*
Baseline ID*

Patients

Patient NumberTreatmentOutcomeDate
10 2001-06-07
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