BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CERVICAL RIPENING BALLOON 18.0FR, 40 CM, 80 ML

    MDR report key: 3893889 · Received June 19, 2014

    Report

    Report Number
    MW5036795
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    COOK
    Product Code
    HDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PROXIMAL BALLOON ON THE COOK CERVICAL RIPENING BALLOON FAILED TO DEFLATE. DIAGNOSIS OR REASON FOR USE: PREGNANCY - FOR CERVICAL RIPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361786 COOK CERVICAL RIPENING BALLOON 18.0FR, 40 CM, 80 ML CERVICAL RIPENING BALLOON HDY COOK U2452709

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention