BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1760210 · Received July 12, 2010

    Report

    Report Number
    2647580-2010-00619
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Report Date
    June 11, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: TEPP-PROCEDURE, INGUINAL HERNIA. PT GENDER: UNK. ACCORDING TO THE RPTR: THE PDB-BALLOON BURST INSIDE THE PT DURING THE OPERATION. NO PIECES FELL IN THE CAVITY, NEITHER THE OPERATING ROOM TIME NOR THE SIZE OF THE INCISION WERE EXTENDED, THERE WAS NO TISSUE DAMAGE AND THERE WAS NO ADDITIONAL BLEEDING. NO ADDITIONAL INFO AVAILABLE. PT IS FINE, THEY USED ANOTHER BALLOON TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P9G0829

    Patients

    Seq Age Sex Outcome Treatment
    1