RUSCH EQUIPLED BLADEMAC 4 5844

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-20 for RUSCH EQUIPLED BLADEMAC 4 5844 manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number8030121-2020-00054
MDR Report Key9862422
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-20
Date of Report2020-03-03
Date of Event2020-02-23
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactVICTORIA SANDLIN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer G1TRUPHATEK INTERNATIONAL LTD.
Manufacturer Street14 BENNY GAON STREET P.O. 8051
Manufacturer CityNETANYA 4250443
Manufacturer CountryIS
Manufacturer Postal Code4250443
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH EQUIPLED BLADEMAC 4
Generic NameLARYNGOSCOPE, RIGID
Product CodeCCW
Date Received2020-03-20
Catalog Number5844
Lot Number181201
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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