BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEDISH ADJUSTABLE GASTRIC BAND

    MDR report key: 1060749 · Received June 13, 2008

    Report

    Report Number
    3005992282-2008-00082
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    March 25, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BAND PROCEDURE, THE INJECTION PORT DISCONNECTED AND THE CATHETER BROKE AT THE JUNCTION WITH THE BOX. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEDISH ADJUSTABLE GASTRIC BAND LTI OBTECH MEDICAL SARL NA 0111003

    Patients

    Seq Age Sex Outcome Treatment
    1