WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-19 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.

MAUDE Entry Details

Report Number3002807350-2019-00007
MDR Report Key9085649
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-09-19
Date of Report2019-09-13
Date of Event2019-06-19
Date Facility Aware2019-08-19
Report Date2019-09-13
Date Reported to FDA2019-09-13
Date Reported to Mfgr2019-09-13
Date Mfgr Received2019-08-22
Device Manufacturer Date2018-11-12
Date Added to Maude2019-09-19
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 ContactMS. CHIA CHIN YIN
Manufacturer Street440 ANG MO KIO INDUSTRIAL PARK 1
Manufacturer CitySINGAPORE, 569620
Manufacturer CountrySN
Manufacturer Postal569620
Manufacturer G1PT. JMS BATAM CAMMO INDUSTRIAL PARK
Manufacturer StreetCAMMO INDUSTRIAL PARK BLK. F, NO.2, BATAM CENTRE
Manufacturer CityINDONESIA, 29461
Manufacturer CountryID
Manufacturer Postal Code29461
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP
Generic NameJMS WINGEATER A.V.FISTULA NEEDLE SET
Product CodeFIE
Date Received2019-09-19
Model Number820-5002-33
Lot Number181112351
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age7 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJMS SINGAPORE PTE LTD
Manufacturer Address440 ANG MO KIO INDUSTRIAL PARK 1 SINGAPORE, 569620 SN 569620


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-09-19

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