TANGO REFLEX LT5106-T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-03 for TANGO REFLEX LT5106-T manufactured by Ellex Medical Pty Ltd.

MAUDE Entry Details

• Report Number: 3002806902-2019-00005
• MDR Report Key: 8954467
• Report Source: COMPANY REPRESENTATIVE,DISTRI
• Date Received: 2019-09-03
• Date of Report: 2019-07-21
• Date of Event: 2019-07-09
• Date Facility Aware: 2019-07-21
• Report Date: 2019-08-10
• Date Reported to Mfgr: 2019-08-10
• Date Mfgr Received: 2019-08-10
• Device Manufacturer Date: 2017-02-23
• Date Added to Maude: 2019-09-03
• 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: 3
• Manufacturer Contact: MR. ANDREW PFEIFFER
• Manufacturer Street: 3-4 SECOND AVENUE
• Manufacturer City: MAWSON LAKES, SOUTH AUSTRALIA 5095
• Manufacturer Country: AS
• Manufacturer Postal: 5095
• Manufacturer G1: ELLEX MEDICAL PTY LTD
• Manufacturer Street: 3-4 SECOND AVENUE
• Manufacturer City: MAWSON LAKES, 5095
• Manufacturer Country: AS
• Manufacturer Postal Code: 5095
• Single Use: 3
• Remedial Action: NO
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TANGO REFLEX
• Generic Name: OPHTHALMIC LASER
• Product Code: HQF
• Date Received: 2019-09-03
• Model Number: LT5106-T
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 30 MO
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ELLEX MEDICAL PTY LTD
• Manufacturer Address: 3-4 SECOND AVENUE MAWSON LAKES, 5095 AS 5095

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-03