UPSYLON Y MESH KIT M0068318220 72912

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 2019-09-09 for UPSYLON Y MESH KIT M0068318220 72912 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number3005099803-2019-04384
MDR Report Key8978334
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-09-09
Date of Report2019-10-28
Date of Event2019-08-14
Date Mfgr Received2019-09-30
Date Added to Maude2019-09-09
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1PROXY BIOMEDICAL
Manufacturer StreetCOILLEACH
Manufacturer CitySPIDDAL, CO GALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUPSYLON Y MESH KIT
Generic NameGYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
Product CodeOHD
Date Received2019-09-09
Model NumberM0068318220
Catalog Number72912
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-09

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