PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-09-11 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2019-87007
MDR Report Key8994113
Report SourceLITERATURE
Date Received2019-09-11
Date of Report2019-08-15
Date Mfgr Received2019-08-15
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 ContactDARLENE KYLE
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182792
Manufacturer G1ETHICON INC.-SAN LORENZO PR
Manufacturer Street982 ROAD 183 KM 8.3
Manufacturer CitySAN LORENZO
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Generic NameSURGICAL SEALANT
Product CodeOMD
Date Received2019-09-11
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
101. Required No Informationntervention 2019-09-11

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