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 2006-02-10 for IRIX 70 manufactured by Trophy Radiologie.

Event Text Entries

[402900] Notified that irix 70 scissor arm was cracking, then broke.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020825-2006-00001
MDR Report Key677034
Report Source05
Date Received2006-02-10
Date of Report2006-02-03
Date of Event2006-01-14
Report Date2006-02-02
Device Manufacturer Date1995-04-01
Date Added to Maude2006-02-21
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 Phone6785898673
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 Received2006-02-10
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key666318
ManufacturerTROPHY RADIOLOGIE
Manufacturer Address4 RUE F. PELLOUTIER 77437 MARNE LA VALLEE CROISSY-BEAUBOURG CEDEX 2 FR


Patients

Patient NumberTreatmentOutcomeDate
10 2006-02-10

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