BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 953106 · Received November 16, 2007

    Report

    Report Number
    3005992282-2007-00010
    Event Type
    Injury
    Date Received
    November 16, 2007
    Date of Event
    October 29, 2007
    Report Date
    November 16, 2007
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    PMA / PMN Number
    P070009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/16/2007. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. PRODUCT CODE 2100-X HAS SIMILAR BALLOON AS THE RLZB22 SOLD IN THE US.

    Description of Event or Problem · 1

    A LEAK IN THE BAND WAS DETECTED 4 YEARS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICK CLOSE LTI OBTECH MEDICAL SARL 2100-X NI

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention