BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER EXTRA VIEW BALLOON - VIEW

    MDR report key: 1932827 · Received December 2, 2010

    Report

    Report Number
    2647580-2010-00942
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 23, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. PT GENDER: UNK. ACCORDING TO THE REPORTER: THE BALLOON DID NOT INFLATE WHEN INSERTED INTO THE ABDOMEN. OPENED ANOTHER DISTENSION BALLOON. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER EXTRA VIEW BALLOON - VIEW DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0G0403

    Patients

    Seq Age Sex Outcome Treatment
    1