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 2004-11-03 for IRIX-70 manufactured by Trophy Radiologie.

Event Text Entries

[22053926] 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 at that time. The device cited in this report is involved in recall.
Patient Sequence No: 1, Text Type: N, H10


[22178394] Notified in 2004 of a scissor arm breakage at the 1st knuckle.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020825-2004-00032
MDR Report Key874685
Report Source05
Date Received2004-11-03
Date of Report2004-10-28
Date of Event2004-10-13
Date Added to Maude2007-07-05
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 ContactPEGGY BAHT
Manufacturer Street1765 THE EXCHANGE
Manufacturer CityATLANTA GA 30339
Manufacturer CountryUS
Manufacturer Postal30339
Manufacturer Phone6785898556
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
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 Received2004-11-03
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID Number*
OperatorHEALTH PROFESSIONAL
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key854434
ManufacturerTROPHY RADIOLOGIE
Manufacturer Address4 RUE F. PELLOUTIER CROISSY BEAUBOURG MARNE LA VALLEE CEDEX 2 FR 77437


Patients

Patient NumberTreatmentOutcomeDate
10 2004-11-03

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