STEEL SUTURE 18"(45CM) 7 B&S D9499

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-07-24 for STEEL SUTURE 18"(45CM) 7 B&S D9499 manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2019-84624
MDR Report Key8824101
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-07-24
Date of Report2019-06-27
Date of Event2019-06-17
Date Mfgr Received2019-06-27
Device Manufacturer Date2018-11-29
Date Added to Maude2019-07-24
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.-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 NameSTEEL SUTURE 18"(45CM) 7 B&S
Generic NameSUTURE, NONABSORBABLE, STEEL
Product CodeGAQ
Date Received2019-07-24
Returned To Mfg2019-07-18
Catalog NumberD9499
Lot NumberMM5159
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
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 2019-07-24

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