BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH

    MDR report key: 494769 · Received November 4, 2003

    Report

    Report Number
    9610520-2003-00244
    Event Type
    Malfunction
    Date Received
    November 4, 2003
    Report Date
    October 29, 2003
    Manufacturer
    WILLY RUSCH GMBH
    Product Code
    KDH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE BALLOON LEAKED WHILST THE INSTRUMENT WAS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SENGSTAKEN TUBE KDH WILLY RUSCH GMBH NA 01391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention