0 ENDOLOOP LIG W/PDS II EZ10G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for 0 ENDOLOOP LIG W/PDS II EZ10G manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2020-02491
MDR Report Key9904452
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-03-03
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-31
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 ContactDARLENE KYLE
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone9082182792
Manufacturer G1ETHICON INC.-BRAZIL
Manufacturer StreetRODOVIA PRESIDENTE DUTRA KM 154
Manufacturer CitySAO PAOLO 12240
Manufacturer CountryBR
Manufacturer Postal Code12240
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name0 ENDOLOOP LIG W/PDS II
Generic NameCANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY
Product CodeGEA
Date Received2020-03-31
Catalog NumberEZ10G
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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