BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1821467 · Received August 31, 2010

    Report

    Report Number
    3005992282-2010-00253
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 26, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A LAPAROSCOPIC GASTRIC BAND PROCEDURE, DURING A ROUTINE ADJUSTMENT IT WAS NOTICED THAT THE BAND TUBING WAS DISCONNECTED FROM THE INJECTION PORT. A NEW PORT WAS PLACED ON (B)(6), 2010. ADJUSTMENT/FILL HISTORY ASKU. THE DATE WHEN THE PROBLEM WAS FIRST DISCOVERED IS UNKNOWN. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1