BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET MEDICAL 5FGHSG SONOHYSTOGRAM CATH

    MDR report key: 9744638 · Received February 21, 2020

    Report

    Report Number
    MW5093207
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    February 12, 2020
    Report Date
    February 19, 2020
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON ON HSG CATHETER FAILED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205561 ROCKET MEDICAL 5FGHSG SONOHYSTOGRAM CATH CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF ROCKET MEDICAL PLC R57422 480661

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR