GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP 1916G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-11-15 for GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP 1916G manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2019-89985
MDR Report Key9332139
Report SourceFOREIGN,USER FACILITY
Date Received2019-11-15
Date of Report2019-10-28
Date of Event2019-10-25
Date Mfgr Received2019-10-28
Device Manufacturer Date2018-10-31
Date Added to Maude2019-11-15
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 StreetAVIENIDA DE LAS TORRES COL SALVACAR
Manufacturer CityCIUDAD JUAREZ
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP
Generic NameSUTURE, ABSORBABLE, NATURAL
Product CodeGAL
Date Received2019-11-15
Catalog Number1916G
Lot NumberMLU002
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 2019-11-15

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