EVICEL APP DEVICE ACCESSORY TIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for EVICEL APP DEVICE ACCESSORY TIP manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2019-87965
MDR Report Key9101053
Date Received2019-09-20
Date of Report2019-08-22
Date of Event2019-08-22
Date Mfgr Received2019-08-22
Date Added to Maude2019-09-20
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 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182792
Manufacturer G1ETHICON INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEVICEL APP DEVICE ACCESSORY TIP
Generic NameFIBRIN SEALANT PREPARATION DEVICE
Product CodeMZM
Date Received2019-09-20
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 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-20

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