VERSAPOINT ANGLED LOOP 01985

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 2020-03-05 for VERSAPOINT ANGLED LOOP 01985 manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2020-01757
MDR Report Key9792445
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-05
Date of Report2020-02-10
Date of Event2019-11-30
Date Mfgr Received2020-02-10
Date Added to Maude2020-03-05
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.-GYRUS MEDICAL LTD
Manufacturer StreetFORTRAN ROAD
Manufacturer CityCARDIFF CF3 OLT
Manufacturer Postal CodeCF3 OLT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSAPOINT ANGLED LOOP
Generic NameHYSTEROSCOPE (AND ACCESSORIES)
Product CodeHIH
Date Received2020-03-05
Model Number01985
Catalog Number01985
Lot NumberUGY1802009
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
10 2020-03-05

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