RUSCH MRI 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 00 report with the FDA on 2014-04-14 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex.

Event Text Entries

[4541275] The complaint is reported as: the customer alleges that the device will not light up.
Patient Sequence No: 1, Text Type: D, B5

[12021284] The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1044475-2014-00125
• MDR Report Key: 3886523
• Report Source: 00
• Date Received: 2014-04-14
• Date of Report: 2014-04-02
• Date of Event: 2014-04-02
• Date Mfgr Received: 2014-04-02
• Date Added to Maude: 2014-07-08
• 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: 0
• Event Location: 0
• Manufacturer Contact: MARGIE BURTON, RN, REG AFFAIRS
• Manufacturer Street: P.O. BOX 12600
• Manufacturer City: RTP NC 27709
• Manufacturer Country: US
• Manufacturer Postal: 27709
• Manufacturer Phone: 9194334965
• Manufacturer G1: TELEFLEX
• 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 MRI COND FIBER OPTIC LARYN KIT
• Generic Name: MRI LARYNGOSCOPE KIT
• Product Code: OGH
• Date Received: 2014-04-14
• Catalog Number: 005852300
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX
• Manufacturer Address: RTP NC 27709 US 27709

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-04-14