BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT

    MDR report key: 1000979 · Received February 19, 2008

    Report

    Report Number
    3005992282-2008-00008
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 29, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 FOLLOWING A LAP ADJUSTABLE BAND PROCEDURE, THE BAND WAS REMOVED DUE TO ESOPHAGEAL OBSTRUCTION. THE SURGEON INDICATED THAT AFTER AN EXPERIENCE OF GASTROENTERITIS, THE PATIENT MADE CONSIDERABLE EFFORT TO INDUCE HERSELF TO VOMIT. SHE VOMITED TO THE POINT WHERE SHE LOST CONSCIOUSNESS. THE PATIENT HAS NOT HAD ANY OTHER COMPLICATIONS SINCE THE BAND REMOVAL AND IS IN EXCELLENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT LTI LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention