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 Number: 8020825-1999-00051
• MDR Report Key: 254198
• Report Source: 08
• Date Received: 1999-11-29
• Date of Report: 1999-11-29
• Date of Event: 1999-11-01
• Date Mfgr Received: 1999-11-15
• Date Added to Maude: 1999-12-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: PHILIP JUHAS
• Manufacturer Street: 36 APPLE RIDGE RD
• Manufacturer City: DANBURY CT 06810
• Manufacturer Country: US
• Manufacturer Postal: 06810
• Manufacturer Phone: 2037901188
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Removal Correction Number: Z-1099/1101-5
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INTRAORAL X-RAY DENTAL SYSTEM
• Generic Name: RADIOLOGIC
• Product Code: FAP
• Date Received: 1999-11-29
• Model Number: IRIX 70
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NA
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 246144
• Manufacturer: TROPHY RADIOLOGIE / DIVISION OF TREX MEDICAL CORPORATION
• Manufacturer Address: 4 RUE F. PELLOUTER CROISSY BEABOURG MARNE LA VALLEE, CEDEX 2 FR
• Baseline Brand Name: INTRAORAL DENTAL X-RAY SYSTEM 70-X
• Baseline Generic Name: RADIOLOGIC
• Baseline Model No: IRIX 70
• Baseline Catalog No: NA
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-11-29