DISPOSABLE DEFENDO SUCTION VALVE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2019-09-06 for DISPOSABLE DEFENDO SUCTION VALVE manufactured by Medivators.

MAUDE Entry Details

Report Number1651395-2019-00003
MDR Report Key8971027
Report SourceOTHER,USER FACILITY
Date Received2019-09-06
Date of Report2019-09-06
Date of Event2019-08-07
Date Mfgr Received2019-08-07
Date Added to Maude2019-09-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAUREN JOHNSON
Manufacturer Street14605 28TH AVE N
Manufacturer CityPLYMOUTH MN 55447
Manufacturer CountryUS
Manufacturer Postal55447
Manufacturer G1MEDIVATORS
Manufacturer Street3150 POLLOK DRIVE
Manufacturer CityCONROE TX 77303
Manufacturer CountryUS
Manufacturer Postal Code77303
Single Use3
Remedial ActionPM
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDISPOSABLE DEFENDO SUCTION VALVE
Generic NameDISPOSABLE SUCTION VALVE FOR GI ENDOSCOPES
Product CodeODC
Date Received2019-09-06
Lot Number415963
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDIVATORS
Manufacturer Address3150 POLLOK DRIVE CONROE TX 77303 US 77303


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-06

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