BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1241028 · Received November 21, 2008

    Report

    Report Number
    3005992282-2008-00222
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    August 11, 2008
    Report Date
    November 3, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT POST OF LAP GASTRIC BAND PROCEDURE, THE BAND WAS BEING EXPLANTED, DUE TO AN INFECTION. POST OP THE SURGEON NOTICED WHEN EXAMINING THE REMOVED DEVICE THAT THE STRAIN RELIEF TUBING CAME OFF DURING THE EXPLANT PROCEDURE AND HAD BEEN LEFT IN THE PATIENT. THE PATIENT HAS BEEN RELEASED AND IS NOT SCHEDULED FOR AN ADDITIONAL PROCEDURE AT THIS TIME TO REMOVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI OBTECH MEDICAL SARL NA

    Patients

    Seq Age Sex Outcome Treatment
    1