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 2009-06-12 for IRIX 70 manufactured by Trophy Radioligie.

Event Text Entries

[1106456] Irix scissor arm broke at knuckle.
Patient Sequence No: 1, Text Type: D, B5

[8460055] 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. 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 Number: 8020825-2009-00001
• MDR Report Key: 1403285
• Report Source: 05
• Date Received: 2009-06-12
• Date of Report: 2009-06-11
• Date of Event: 2009-06-02
• Device Manufacturer Date: 1995-07-01
• Date Added to Maude: 2011-03-21
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: LINDA SPITZER
• Manufacturer Street: 1765 THE EXCHANGE
• Manufacturer City: ATLANTA GA
• Manufacturer Country: US
• Manufacturer Phone: 7702263518
• Manufacturer G1: TROPHY RADIOLIGIE
• Manufacturer Street: 4 RUE F. PELLOUTIE CROISSY-BEAUBOURG
• Manufacturer City: MARNE LA VALLEE 77437
• Manufacturer Postal Code: 77437
• 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: IRIX 70
• Generic Name: DENTAL X-RAY SYSTEM
• Product Code: EAP
• Date Received: 2009-06-12
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TROPHY RADIOLIGIE
• Manufacturer Address: 4 RUE F. PELLOUTIER

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-06-12