BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE STERIFLATE DISPOSABLE INFLATION DEVICE

    MDR report key: 8301434 · Received February 1, 2019

    Report

    Report Number
    MW5083665
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 29, 2019
    Report Date
    January 31, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KCF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN USING DISPOSABLE INFLATION DEVICE, THE HANDLE WOULD NOT TURN DURING THE PROCEDURE TO INFLATE THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91499 CRE STERIFLATE DISPOSABLE INFLATION DEVICE DILATOR ESOPHAGEAL KCF BOSTON SCIENTIFIC CORPORATION
    91500 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR