BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    831385

    MDR report key: 9960031 · Received April 14, 2020

    Report

    Report Number
    3005798905-2020-02924
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 30, 2020
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE STOPPER - CUSTOMER IS REFERRING TO THE GASKET - APPEARS TO BE THICKER AT TIMES AND IS ALSO SOMETIMES CROOKED. THIS MAKES IT DIFFICULT FOR CUSTOMER TO READ MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421670 831385 EASYTOUCH FMF MHC MEDICAL PRODUCTS, LLC 50195

    Patients

    Seq Age Sex Outcome Treatment
    1