BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 3140847 · Received May 24, 2013

    Report

    Report Number
    MW5030339
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CALIBRATION TUBE HAS A LONG PIG TAIL PORT THAT IS CONNECTED TO AIR, AND A PORT THAT CAN BE USED FOR A BALLOON. THE BALLOON IS NOT INFLATED DURING THE PROCEDURE, BUT DID RUPTURE DURING THE PROCEDURE CAUSING PT INJURY. DIAGNOSIS OF REASON FOR USE: BARIATRIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231985 LAP-BAND SYSTEM CALIBRATION TUBE LTI ALLERGAN B-2017 508869

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization