BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER EXTRA VIEW BALLOON - ROUND

    MDR report key: 1993571 · Received January 21, 2011

    Report

    Report Number
    2647580-2011-00051
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 23, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE BALLOON RUPTURED. THE CONDITION WAS VISUALLY CONFIRMED BY THE USER. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO REPORT OF PT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER EXTRA VIEW BALLOON - ROUND DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0G0822

    Patients

    Seq Age Sex Outcome Treatment
    1