DSD EDGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-07-03 for DSD EDGE manufactured by Medivators.

MAUDE Entry Details

Report Number2150060-2019-00050
MDR Report Key8757620
Report SourceUSER FACILITY
Date Received2019-07-03
Date of Report2019-07-03
Date of Event2019-05-28
Date Mfgr Received2019-06-03
Device Manufacturer Date2018-04-30
Date Added to Maude2019-07-03
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 ContactANN MOUA
Manufacturer Street14605 28TH AVE N
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal55447
Manufacturer Phone7633182956
Manufacturer G1MEDIVATORS
Manufacturer Street14605 28TH AVE N
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDSD EDGE
Generic NameAUTOMATED ENDOSCOPE REPROCESSOR
Product CodeFEB
Date Received2019-07-03
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDIVATORS
Manufacturer Address14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-03

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