BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1083274 · Received July 29, 2008

    Report

    Report Number
    3005992282-2008-00117
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 17, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE GASTRIC BAND COULD NOT INFLATE AFTER MANY ATTEMPTS. THE PROBLEM WAS SOLVED WHEN THE SURGEON, THROUGH A SURGERY, REMOVED THE PORTAL AND CUT A PIECE OF THE SILICONE HOSE, WHERE THERE WAS A FOREIGN MATTER, WHICH ACCORDING TO THE SURGEON MADE IT DIFFICULT FOR THE FILLING SOLUTION TO INFLATE THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICK CLOSE LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention