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 2006-09-30 for IRIX 70 * manufactured by Trophy Radiologie.

Event Text Entries

[614189] Irix scissor arm broke at knuckle.
Patient Sequence No: 1, Text Type: D, B5

[7956447] 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.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 8020825-2006-00009
• MDR Report Key: 856232
• Report Source: 05
• Date Received: 2006-09-30
• Date of Report: 2006-09-28
• Date of Event: 2006-09-11
• Device Manufacturer Date: 1995-01-01
• Date Added to Maude: 2007-05-30
• 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: 3
• Event Location: 0
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Manufacturer Phone: **
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: RL
• 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: 2006-09-30
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 841057
• Manufacturer: TROPHY RADIOLOGIE
• Manufacturer Address: 4 RUE F. PELLOUTIE * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-09-30