BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1387208 · Received May 15, 2009

    Report

    Report Number
    3005992282-2009-00129
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    April 22, 2009
    Report Date
    April 23, 2009
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP A GASTRIC BAND PROCEDURE, FLUOROSCOPY SHOWED THE BAND HAD ERODED INTO THE PATIENT'S STOMACH. THE EROSION WAS CONFIRMED BY ENDOSCOPY. THE BAND IS BEING REMOVED IN 2009. THE PATIENT HAS LOST 83 LBS, 52% EWL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention