PROLENE BLU 45CM M1.5 EH7291H

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 PROLENE BLU 45CM M1.5 EH7291H manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2020-02501
MDR Report Key9908310
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-04
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 ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-JUAREZ
Manufacturer StreetAVENIDA DE LAS TORRES 7125 COL SALVACAR
Manufacturer CityCIUDAD JUAREZ 32604
Manufacturer CountryMX
Manufacturer Postal Code32604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROLENE BLU 45CM M1.5
Generic NameSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Product CodeGAW
Date Received2020-03-31
Catalog NumberEH7291H
Lot NumberPLQ105
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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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