BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1983788 · Received January 20, 2011

    Report

    Report Number
    2647580-2011-00043
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 21, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    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: INGUINAL HERNIA REPAIR. PT GENDER: UNK. ACCORDING TO THE RPTR: THE BALLOON RUPTURED AND THE BROKEN PORTION HAD TO BE REMOVED FROM THE PT. THERE WAS NO REPORTED TISSUE DAMAGE OR BLOOD LOSS. THE SURGERY WAS NOT REPORTED TO HAVE BEEN EXTENDED. NO PT INJURY WAS REPORTED. THE PT CONDITION IS REPORTED AS RECOVERED. THE SAMPLE IS BEING SENT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P9D1058

    Patients

    Seq Age Sex Outcome Treatment
    1