BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1153306 · Received September 9, 2008

    Report

    Report Number
    3005992282-2008-00151
    Event Type
    Injury
    Date Received
    September 9, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 13, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 OF A GASTRIC BAND PROCEDURE IN EARLY 2008, THEY DID A REVISION SURGERY ON SEVEN MONTHS LATER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE ADJUSTABLE GASTRIC BAND WAS DISCONNECTED FROM THE TUBING AND THE PORT OF THE LOCKING CONNECTOR WAS STILL ATTACHED TO THE PORT. THEY USED A NEW KIT AND USED THE PORT, AND THE NEW LOCKING CONNECTOR TO PROCEED WITH THE PROCEDURE AND CORRECT THE PROBLEM. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    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 Other