BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1841331 · Received September 22, 2010

    Report

    Report Number
    3005992282-2010-00278
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE SECONDARY TO NECROSIS OF THE SMALL BOWEL THE REALIZE BAND WAS REMOVED FOR PRECAUTIONARY REASONS. THE STRAIN RELIEF WAS OBSERVED TO BE FREE FLOATING ALONG THE BAND TUBING. WHEN THE BAND WAS REMOVED, IT DETACHED AND FELL INTO THE ABDOMEN. IT WAS NOT RETRIEVED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1