BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H/S CATHETER SET FOR HYSTEROSALPINGOGRAPHY

    MDR report key: 284526 · Received June 30, 2000

    Report

    Report Number
    MW1019219
    Event Type
    Malfunction
    Date Received
    June 30, 2000
    Date of Event
    June 29, 2000
    Report Date
    June 30, 2000
    Manufacturer
    ACKRAD LABORATORIES
    Product Code
    HDN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE BALLOON ON THE CATHETERS WOULD NOT STAY INFLATED FOR THE PROCEDURE. IN ONE CASE, THE BALLOON POPPED. SIX CATHETERS WERE TESTED, AND ALL FAILED. CATHETERS WERE ALL THE SAME PRODUCT NUMBER, AND CAME FROM 4 DIFFERENT LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H/S CATHETER SET FOR HYSTEROSALPINGOGRAPHY CATHETER WITH BALLOON HDN ACKRAD LABORATORIES 6150077F 8445; 8309; 7979; 7440

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other