BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/OVAL BALLOON DISSECTOR

    MDR report key: 1993549 · Received January 21, 2011

    Report

    Report Number
    2647580-2011-00048
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 23, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE BALLOON WOULD NOT INFLATE. NO PT INJURY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS BTT/OVAL BALLOON DISSECTOR DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0H1156

    Patients

    Seq Age Sex Outcome Treatment
    1