BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE LAP BAND

    MDR report key: 2875344 · Received November 27, 2012

    Report

    Report Number
    2875344
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING ADJUSTABLE BAND, SURGEON PULLED THE BAND THROUGH THE NOTCH, THE BAND DID NOT CATCH ON NOTCH AS INTENDED. MD TRIED TO BACK IT OUT AND IT DIDN'T CATCH THAT WAY. SURGEON REMOVED BAND AND USED ANOTHER BAND TO COMPLETE THE PROCEDURE. BAND GIVEN TO CLINICAL RESOURCE NURSE TO NOTIFY PRODUCT REP. BAND MODEL RLZB32D1 LOT ZMFBBF. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE LAP BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ETHICON ENDO-SURGERY, INC. RLZB32D1 ZMFBBF

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR