GUT PL UD 27IN 5-0 S/A FS-2 H820G

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 2020-01-15 for GUT PL UD 27IN 5-0 S/A FS-2 H820G manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2020-00413
MDR Report Key9593216
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-15
Date of Report2019-12-20
Date Mfgr Received2020-01-29
Date Added to Maude2020-01-15
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.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGUT PL UD 27IN 5-0 S/A FS-2
Generic NameSUTURE, ABSORBABLE, NATURAL
Product CodeGAL
Date Received2020-01-15
Returned To Mfg2020-01-29
Model NumberH820G
Catalog NumberH820G
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2020-01-15

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