BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND

    MDR report key: 2072899 · Received April 29, 2011

    Report

    Report Number
    3005992282-2011-00103
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 31, 2009
    Report Date
    April 11, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A "LAP BAND" PROCEDURE. SUBSEQUENT TO THE PROCEDURE FROM (B)(6) 2009 THROUGH (B)(6) 2010 THE PATIENT STATES "SUFFERED FROM PAIN AND CONSTANT DRAINAGE AT THE PORT SITE IN HER ABDOMEN." ON (B)(6) 2009 AND (B)(6) 2010 TWO CORRECTIVE PROCEDURES WERE PERFORMED AND ON (B)(6) 2010, THE PATIENT PULLED A PIECE OF PLASTIC TUBING FROM THE PORT SITE. THE PORT SIGHT CLOSED UP AND HEALED WITHIN A FEW DAYS OF REMOVING THE PLASTIC TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention