BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE INJECTION PORT AND APP

    MDR report key: 1033814 · Received April 24, 2008

    Report

    Report Number
    3005992282-2008-00065
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    December 1, 2007
    Report Date
    March 28, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 OPERATIVE TO GASTRIC BANDING, THE PORT WAS FLIPPED AND THE PATIENT DEVELOPED A POST OP ABSCESS, WHICH WAS DRAINED AT THE EMERGENCY ROOM. THE WOUND WAS PACKED AND ANTIBIOTICS ADMINISTERED. THE WOUND WAS PACKED FOR APPROXIMATELY TWO TO THREE WEEKS UNTIL IT HEALED. THERE WERE NO OTHER REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE INJECTION PORT AND APP LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1