PESS.SH.STEM FLEX 2 INCH MXPGSS2-

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-28 for PESS.SH.STEM FLEX 2 INCH MXPGSS2- manufactured by Coopersurgical, Inc..

MAUDE Entry Details

Report Number1216677-2020-00006
MDR Report Key9639402
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-01-28
Date of Report2020-01-25
Date of Event2019-12-13
Date Mfgr Received2020-01-13
Device Manufacturer Date2019-05-29
Date Added to Maude2020-01-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PETER NIZIOLEK
Manufacturer Street50 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1COOPERSURGICAL, INC.
Manufacturer Street75 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal Code06611
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePESS.SH.STEM FLEX 2 INCH
Generic NamePESS.SH.STEM FLEX 2 INCH
Product CodeHHW
Date Received2020-01-28
Model NumberMXPGSS2-
Catalog NumberMXPGSS2-
Lot Number249611
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-28

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