TOTAL PELVIC FLOOR REPAIR SYST PFRT01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-29 for TOTAL PELVIC FLOOR REPAIR SYST PFRT01 manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2019-90189
MDR Report Key9392000
Report SourceOTHER
Date Received2019-11-29
Date of Report2019-11-20
Date Mfgr Received2019-11-20
Device Manufacturer Date2007-02-22
Date Added to Maude2019-11-29
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 SARL-NEUCHATEL
Manufacturer StreetPUITS-GODET 20
Manufacturer CityNEUCHATEL
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTOTAL PELVIC FLOOR REPAIR SYST
Generic NameMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Product CodeOTP
Date Received2019-11-29
Catalog NumberPFRT01
Lot Number3007940
Device Expiration Date2010-01-31
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 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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