BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBERA INTRAGASTRIC BALLOON

    MDR report key: 5162640 · Received October 20, 2015

    Report

    Report Number
    3006722112-2015-00474
    Event Type
    Injury
    Date Received
    October 20, 2015
    Report Date
    September 30, 2015
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 10/20/2015. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. PAIN IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, TREATMENT DATE, EXPLANT DATE, DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: POSSIBLE COMPLICATIONS OF THE USE OF THE ORBERA¿ SYSTEM INCLUDE: ABDOMINAL OR BACK PAIN, EITHER STEADY OR CYCLIC.

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING DISCOMFORT. IV MEDICATION USED TO TREAT THE EVENT. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691250 ORBERA INTRAGASTRIC BALLOON IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention