RUSCH MIR COND FIBER OPTIC LARYN KIT 005852300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-01-26 for RUSCH MIR COND FIBER OPTIC LARYN KIT 005852300 manufactured by .

Event Text Entries

[5180985] The customer alleges that the miller 2 blade is no longer making a connection to light up the pipe. No pt injury or consequence.
Patient Sequence No: 1, Text Type: D, B5

[12895491] (b)(4). The device sample was not returned for eval at the time of this report.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1044475-2015-00037
• MDR Report Key: 4460512
• Report Source: 06,07
• Date Received: 2015-01-26
• Date of Report: 2014-01-09
• Date of Event: 2014-01-08
• Date Mfgr Received: 2015-01-09
• Date Added to Maude: 2015-02-19
• 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: MARGIE BURTON, RN
• Manufacturer Street: 3015 CARRINGTON MILL BLVD
• Manufacturer City: MORRISVILLE NC 27709
• Manufacturer Country: US
• Manufacturer Postal: 27709
• Manufacturer Phone: 9194334965
• Manufacturer G1: TELEFLEX MEDICAL
• Manufacturer Street: 2917 WECK DR.
• Manufacturer City: RESEARCH TRIANGLE PARK NC 27709
• Manufacturer Country: US
• Manufacturer Postal Code: 27709
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RUSCH MIR COND FIBER OPTIC LARYN KIT
• Generic Name: LARYNGOSCOPE KIT
• Product Code: OGH
• Date Received: 2015-01-26
• Catalog Number: 005852300
• Lot Number: 131401
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-01-26