THIN PREP PAP 500 TSTS/CS 02500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-02-13 for THIN PREP PAP 500 TSTS/CS 02500 manufactured by Coopersurgical, Inc..

MAUDE Entry Details

Report Number1216677-2020-00053
MDR Report Key9707598
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2020-02-13
Date of Report2020-02-13
Date of Event2020-01-31
Date Mfgr Received2020-02-04
Date Added to Maude2020-02-13
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
Manufacturer CountryUS
Manufacturer Phone6015200334
Manufacturer G1COOPERSURGICAL, INC.
Manufacturer Street75 CORPORATE DRIVE
Manufacturer CityTRUMBULL, CT
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHIN PREP PAP 500 TSTS/CS
Generic NameTHIN PREP PAP 500 TSTS/CS
Product CodeHHT
Date Received2020-02-13
Model Number02500
Catalog Number02500
Lot NumberNOT PROVIDED
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL, CT US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-13

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