BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 4142794 · Received September 23, 2014

    Report

    Report Number
    2024601-2014-00534
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NAUSEA, VOMITING, AND BAND SLIPPAGE ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED NAUSEA, VOMITING, AND A SLIPPED LAP-BAND. THE EVENT WAS FIRST NOTICED WHEN PATIENT EXPERIENCED NAUSEA AND VOMITING AND FIRST DIAGNOSED "WHEN THEY WERE NOT ABLE TO PLACE OR WITHDRAW FLUID". THE WHOLE LAP-BAND SYSTEM WAS REMOVED AND WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590990 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2224046

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention DILAUDID| ZETIA| ALPRAZOLAM| POTASSIUM| LASIX| LEVOTHYROXINE| NEXIUM