BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1760209 · Received July 12, 2010

    Report

    Report Number
    2647580-2010-00616
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 10, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GEX
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE INITIAL REPORT SENT: (B)(6) 2010.

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. PT GENDER: UNK. ACCORDING TO THE RPTR: THE CUSTOMER REPORTS THAT THE SURGEON DEFLATED THE BALLOON AND PULLED OUT THE TROCAR. HOWEVER, THE BALLOON FELL INSIDE THE PT. THE SURGEON RETRIEVED THE BALLOON. THE PT RECOVERED. NO SAMPLE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GEX USSC PUERTO RICO P0A1104

    Patients

    Seq Age Sex Outcome Treatment
    1