BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2018967 · Received March 15, 2011

    Report

    Report Number
    3005992282-2011-00075
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    September 10, 2010
    Report Date
    February 17, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW CONDUCTED WITH THE USER FACILITY CONTACT AND WAS INFORMED THAT "I NO LONGER EVEN KNOW THE NAME OF THE PT. WE DE IDENTIFY ALL OF THE PHI SO UNABLE TO REVIEW."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1