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 06,07 report with the FDA on 2014-03-06 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex.

Event Text Entries

[4406320] The complaint is reported as: the blades do not illuminate at all times and some do not function at all. The alleged issues was detected during testing of the device. The customer reports that they disposed of two batteries that were not functioning.
Patient Sequence No: 1, Text Type: D, B5


[12011554] 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 Number1044475-2014-00049
MDR Report Key3837911
Report Source06,07
Date Received2014-03-06
Date of Report2014-02-10
Date of Event2014-02-10
Date Mfgr Received2014-02-10
Date Added to Maude2014-06-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARGIE BURTON, RN
Manufacturer StreetPO BOX 12600
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX
Manufacturer Street2917 WECK DR.
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH MRI COND FIBER OPTIC LARYN KIT
Generic NameLARYNGOSCOPE KIT
Product CodeCAL
Date Received2014-03-06
Catalog Number005852300
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressRTP NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-06

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