BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1900761 · Received November 16, 2010

    Report

    Report Number
    3005992282-2010-00362
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    March 22, 2010
    Report Date
    October 28, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED POST IMPLANT OF A LAPAROSCOPIC ADJUSTABLE BAND, A PINHOLE LEAK WAS IDENTIFIED IN THE BAND TUBING ON (B)(6) 2010. THE BAND TUBING WAS STILL ATTACHED TO THE PORT. THE PORT WAS REPLACED. THE PATIENT HAD A SECOND REVISION ON (B)(6) 2010. IT WAS FOUND THAT THE TUBING HAD DISCONNECTED FROM THE PORT, THE METAL COMPONENT OF THE PORT CONNECTOR WAS STILL CONNECTED TO THE PORT BUT THE STRAIN RELIEF WAS NOT. THE STRAIN RELIEF WAS FOUND IN THE FASCIA. THE TUBING WAS FLOATING AROUND IN THE ABDOMEN. A PROCEDURE WAS PERFORMED TO RECONNECT THE TUBING TO THE PORT. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1