BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN

    MDR report key: 2771553 · Received September 27, 2012

    Report

    Report Number
    MW5027093
    Event Type
    Injury
    Date Received
    September 27, 2012
    Date of Event
    May 3, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, (B)(6) UNDERWENT HIATAL HERNIA REPAIR AND LAP BAND REMOVAL SURGERY. THE POUCH CREATED BY THE BAND BECAME DILATED AND COULD NOT RESOLVE ITSELF WITHOUT SURGERY. PT HAD NO HISTORY OF REFLUX OR HERNIA IN 2006 WHEN LAPBAND WAS PUT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN LAPBAND LTI ALLERGAN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R