BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    MDR report key: 2070623 · Received April 27, 2011

    Report

    Report Number
    3005992282-2011-00101
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 2, 2009
    Report Date
    April 19, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A BAND LEAKAGE WAS REPORTED FOR A PATIENT ENROLLED IN THE (B)(4). IN (B)(6) 2009, THE DOCTOR CONSIDERED THAT THE BAND WAS LEAKING BECAUSE THE FILLS WERE NOT WORKING. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED IN SLEEVE GASTRECTOMY. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZHFB79

    Patients

    Seq Age Sex Outcome Treatment
    1