BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO-MATIC INSUFFLATION VERESS NEEDLE

    MDR report key: 9920703 · Received April 2, 2020

    Report

    Report Number
    MW5094030
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 1, 2020
    Manufacturer
    COOPER SURGICAL, INC.
    Product Code
    FHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RED PLASTIC BLOCKING DELIVERY HOLE OF VERESS NEEDLE X 2 WITH SAME LOT NUMBER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382672 PNEUMO-MATIC INSUFFLATION VERESS NEEDLE PNEUMOPERITONEUM NEEDLE FHP COOPER SURGICAL, INC. 900-200 277792
    382673 PNEUMO-MATIC INSUFFLATION VERESS NEEDLE PNEUMOPERITONEUM NEEDLE FHP COOPER SURGICAL, INC. 900-200 277792

    Patients

    Seq Age Sex Outcome Treatment
    1