IRIX 70

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-10-08 for IRIX 70 manufactured by Trophy Radiologie.

Event Text Entries

[945248] Irix scissor arm broke at knuckle. Arm fell and struck pt on or about head. Medical attention was obtained. Pt name not disclosed.
Patient Sequence No: 1, Text Type: D, B5


[8198346] The reported condition is attributed to a failure of the support arm. This condition was identified by the mfr in 1995 and corrective actions were instituted. The device cited in this report is involved in recall z-1099/1101-5.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8020825-2008-00003
MDR Report Key1193545
Report Source05,08
Date Received2008-10-08
Date of Report2008-08-10
Date of Event2008-07-23
Device Manufacturer Date1993-06-01
Date Added to Maude2010-04-16
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 FDA0
Event Location0
Manufacturer ContactLINDA SPITZER
Manufacturer Street1765 THE EXCHANGE
Manufacturer CityATLANTA GA 30339
Manufacturer CountryUS
Manufacturer Postal30339
Manufacturer Phone7702263518
Manufacturer G1TROPHY RADIOLOGIE
Manufacturer Street4 RUE F. PELLOUTIER CROISSY-BEAUBORG
Manufacturer CityMARNE LA VALLEE CEDEX 2 77437
Manufacturer CountryFR
Manufacturer Postal Code77437
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 Received2008-10-08
Returned To Mfg2008-07-30
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTROPHY RADIOLOGIE
Manufacturer Address4 RUE F. PELLOUTIER


Patients

Patient NumberTreatmentOutcomeDate
10 2008-10-08

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