IRIX 70 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-31 for IRIX 70 * manufactured by Trophy Radioligie.

Event Text Entries

[529248] Irix scissor arm broke at knuckle.
Patient Sequence No: 1, Text Type: D, B5


[7919313] The reported condition is attributed to a failure of the support arm. This condition was identified by the manufacturer in 1995 and corrective actions were instituted. The device cited in this report is involved in recall.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8020825-2006-00008
MDR Report Key775072
Report Source05
Date Received2006-08-31
Date of Report2006-07-19
Date of Event2006-07-10
Device Manufacturer Date1995-05-01
Date Added to Maude2006-11-02
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 ContactLINDA SPITZER
Manufacturer Street1765 THE EXCHANGE
Manufacturer CityATLANTA GA 30339
Manufacturer CountryUS
Manufacturer Postal30339
Manufacturer Phone*
Manufacturer G1TROPHY RADIOLIGIE
Manufacturer Street4 RUE F. PELLOUTIE MARNE LA VALLEE
Manufacturer CityCROISSY-BEAUBOURG
Manufacturer Country*
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-1099/1101-5
Event Type3
Type of Report3

Device Details

Brand NameIRIX 70
Generic NameDENTAL X-RAY SYSTEM
Product CodeEAP
Date Received2006-08-31
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key762851
ManufacturerTROPHY RADIOLIGIE
Manufacturer Address4 RUE F. PELLOUTIE * *


Patients

Patient NumberTreatmentOutcomeDate
10 2006-08-31

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