INTRAORAL X-RAY DENTAL SYSTEM IRIX 70 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1999-11-29 for INTRAORAL X-RAY DENTAL SYSTEM IRIX 70 NA manufactured by Trophy Radiologie / Division Of Trex Medical Corporation.

Event Text Entries

[175798] It was reported that the scissors-arm broke. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020825-1999-00051
MDR Report Key254198
Report Source08
Date Received1999-11-29
Date of Report1999-11-29
Date of Event1999-11-01
Date Mfgr Received1999-11-15
Date Added to Maude1999-12-16
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 Location3
Manufacturer ContactPHILIP JUHAS
Manufacturer Street36 APPLE RIDGE RD
Manufacturer CityDANBURY CT 06810
Manufacturer CountryUS
Manufacturer Postal06810
Manufacturer Phone2037901188
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 NameINTRAORAL X-RAY DENTAL SYSTEM
Generic NameRADIOLOGIC
Product CodeFAP
Date Received1999-11-29
Model NumberIRIX 70
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key246144
ManufacturerTROPHY RADIOLOGIE / DIVISION OF TREX MEDICAL CORPORATION
Manufacturer Address4 RUE F. PELLOUTER CROISSY BEABOURG MARNE LA VALLEE, CEDEX 2 FR
Baseline Brand NameINTRAORAL DENTAL X-RAY SYSTEM 70-X
Baseline Generic NameRADIOLOGIC
Baseline Model NoIRIX 70
Baseline Catalog NoNA
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 1999-11-29

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