ENDOSONIC CLEANER 100V (OT) 7500617

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-11 for ENDOSONIC CLEANER 100V (OT) 7500617 manufactured by Keymed (medical And Industrial Equipment) Ltd..

MAUDE Entry Details

Report Number9611174-2019-00019
MDR Report Key8989989
Date Received2019-09-11
Date of Report2019-09-11
Date Mfgr Received2019-08-26
Device Manufacturer Date2017-03-01
Date Added to Maude2019-09-11
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 PETER MORCOS
Manufacturer StreetKEYMED HOUSE, STOCK ROAD
Manufacturer CitySOUTHEND ON SEA, ESSEX SS25QH
Manufacturer CountryUK
Manufacturer PostalSS25QH
Manufacturer Phone0441702616
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameENDOSONIC CLEANER 100V (OT)
Generic NameENDOSONIC CLEANER
Product CodeFLG
Date Received2019-09-11
Model Number7500617
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerKEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
Manufacturer AddressKEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA, ESSEX SS2 5QH UK SS2 5QH


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-11

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