BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2133268 · Received May 11, 2011

    Report

    Report Number
    2647580-2011-00325
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Report Date
    April 14, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TEP. ACCORDING TO THE REPORTER: DR TRIED TO INFLATE THE BALLOON IN CAVITY, BUT IT COULD NOT BE FULLY INFLATED. THE DEVICE WAS TAKEN OUT AND INFLATED OUT OF THE CAVITY, THEN IT COULD BE FULLY INFLATED. IT WOULD NOT BE INFLATED GOOD IN CAVITY AFTER THAT. USED OTHER DEVICE. NO BLEEDING. NOTHING FELL INTO THE PT CAVITY. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINS. NO PT INJURY WAS REPORTED. NO PT INFO AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1