SUPER SHEATH IS0724

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 2020-02-11 for SUPER SHEATH IS0724 manufactured by Togo Medikit Co. Ltd..

MAUDE Entry Details

Report Number9612126-2020-00003
MDR Report Key9693130
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-02-11
Date of Report2020-02-11
Date of Event2020-01-17
Date Mfgr Received2020-01-21
Date Added to Maude2020-02-11
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 ContactYASHASWINI PATWARDHAN
Manufacturer StreetAMSELWEG 5
Manufacturer CityRHEDA-WIEDENBRUECK, 33378
Manufacturer CountryGM
Manufacturer Postal33378
Manufacturer G1TOGO MEDIKIT CO. LTD.
Manufacturer Street17148-6 AZA KAMEKAWA OAZA HICHIYA
Manufacturer CityHYUGA CITY, 883-0062
Manufacturer CountryJA
Manufacturer Postal Code883-0062
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPER SHEATH
Generic NameDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Product CodeDRE
Date Received2020-02-11
Catalog NumberIS0724
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTOGO MEDIKIT CO. LTD.
Manufacturer Address17148-6 AZA KAMEKAWA OAZA HICHIYA HYUGA CITY, 883-0062 JA 883-0062


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-11

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