BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO-MATIC INSUFFLATION NEEDLE

    MDR report key: 6947550 · Received October 13, 2017

    Report

    Report Number
    MW5072745
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    COOPER SURGICAL
    Product Code
    FHO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COOPER SURGICAL, PNEUMO-MATIC INSUFFLATION NEEDLES WOULD NOT PASS LEAK TEST PRIOR TO USE. TWO DIFFERENT LOT NUMBERS WERE NOTED FROM THE THREE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729551 PNEUMO-MATIC INSUFFLATION NEEDLE VERESS NEEDLE FHO COOPER SURGICAL 900-200 225665
    729552 PNEUMO-MATIC INSUFFLATION NEEDLE VERESS NEEDLE FHO COOPER SURGICAL 900-210 186236

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR