BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    MDR report key: 2221726 · Received August 24, 2011

    Report

    Report Number
    3005992282-2011-00179
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE REMAINS IMPLANTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONSUMER THAT THE BAND WAS ORIGINALLY IMPLANTED IN (B)(6). SHE SOUGHT A SURGEON IN THE US DUE TO DIFFICULTY SWALLOWING SOLID FLUIDS. A EGD WAS PERFORMED ON (B)(6) 2011. PER THE CONSUMER, WHEN THE AREA WAS VIEWED THE BAND COULD NOT BE VISUALIZE. IN ADDITION, WAS INFORMED THAT THE TUBING IS FREE FLOATING IN HER ABDOMEN. SHE STATES THAT SHE HAS HAD AN UPPER GI AND BARIUM SWALLOW AND IT HAS NOT BEEN DETERMINED WHY SHE IS HAVING DIFFICULTY SWALLOWING. PER THE CONSUMER, THE SURGEON HAS INDICATED THAT THE BAND IS MOST LIKELY ENCAPSULATED AND BECAUSE IT IS MEANT TO IMPLANTED, THERE IS NO RISK. THE SURGEON THAT SHE IS CURRENTLY SEEING IS NOT A BANDING SURGEON. SHE STATES THAT SHE IS WILLING TO LIVE WITH THE ADVICE FROM THE SURGEON AND IS NOT WILLING TO RETURN TO MEXICO TO BE FURTHER EVALUATED BY THE IMPLANTING SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR