BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIVAL BALLOON

    MDR report key: 1791960 · Received August 10, 2010

    Report

    Report Number
    1791960
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BARD
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ANGIOPLASTY BALLOON RUPTURED - PT TAKEN TO OPERATING ROOM TO RETRIEVE FRAGMENTED PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIVAL BALLOON ANGIOPLASTY BALLOON LIT BARD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention