BULB TIP YANKAUER WITH VENT 0034880

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 2019-07-26 for BULB TIP YANKAUER WITH VENT 0034880 manufactured by Conmed Corporation.

MAUDE Entry Details

Report Number1320894-2019-00270
MDR Report Key8830944
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-07-26
Date of Report2019-09-19
Date Mfgr Received2019-09-18
Device Manufacturer Date2018-08-27
Date Added to Maude2019-07-26
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 ContactMR. JOHN BERGA
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995358
Manufacturer G1CONMED CORPORATION
Manufacturer Street525 FRENCH ROAD
Manufacturer CityUTICA NY 135025994
Manufacturer CountryUS
Manufacturer Postal Code135025994
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBULB TIP YANKAUER WITH VENT
Generic NameAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Product CodeGCX
Date Received2019-07-26
Returned To Mfg2019-08-02
Catalog Number0034880
Lot Number201808271
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCONMED CORPORATION
Manufacturer Address525 FRENCH ROAD UTICA NY 135025994 US 135025994


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-26

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