BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2242445-1999-00056

    MDR report key: 256977 · Received December 21, 1999

    Report

    Report Number
    2242445-1999-00056
    Event Type
    Malfunction
    Date Received
    December 21, 1999
    Date of Event
    November 15, 1999
    Report Date
    December 20, 1999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON ON THE CATHETER RUPTURED IN SITU. THERE WERE NO PATIENT COMPLICATIONS.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other