BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1514820 · Received October 21, 2009

    Report

    Report Number
    3005992282-2009-00308
    Event Type
    Injury
    Date Received
    October 21, 2009
    Date of Event
    September 28, 2009
    Report Date
    September 28, 2009
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/21/2009. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIX WEEKS POST-OP A LAPAROSCOPIC ADJUSTABLE BAND PROCEDURE, THE SURGEON NOTICED THAT THE PORT HAD FLIPPED. THE PORT WAS COMPLETELY DISENGAGED AND FLIPPED. ALL FOUR HOOKS WERE DISENGAGED. THE PORT WAS REPLACED IN 2009. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI OBTECH MEDICAL SARL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention