BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS SBT/ OVAL BALLOON DISSECTOR

    MDR report key: 1210039 · Received October 21, 2008

    Report

    Report Number
    1219930-2008-00753
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 15, 2008
    Manufacturer
    NORTH HAVEN- USS
    Product Code
    GDI
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 10/21/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE BALLOON DISSECTOR DISENGAGED FROM THE SHAFT UPON REMOVAL OF THE DEVICE. ALL PIECES WERE RETRIEVED. OR TIME WAS DELAYED 5 MINS. NO TISSUE DAMAGE, BLEEDING OR PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS SBT/ OVAL BALLOON DISSECTOR DISPOSABLE SURGICAL ACCESS DEVICE GDI NORTH HAVEN- USS U8A149L

    Patients

    Seq Age Sex Outcome Treatment
    1