BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1832177 · Received September 13, 2010

    Report

    Report Number
    3005992282-2010-00269
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Report Date
    September 2, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED POST IMPLANT A REALIZE BAND, PATIENT HAD INTERMITTENT ABDOMINAL PAIN AND A LOSS OF RESTRICTION. THE TUBING DISCONNECTED FROM THE PORT. THE STRAIN RELIEF AND LOCKING CONNECTOR WERE STILL CONNECTED. THE PORT WAS REPLACED AND RECONNECTED TO THE TUBING. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010. PRIOR TO FIRST USE, THE BLADE WOULD NOT TURN. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1