BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2020339 · Received March 16, 2011

    Report

    Report Number
    3005992282-2011-00076
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 29, 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 UP CONDUCTED WITH THE USER FACILITY CONTACT AND WAS ADVISED 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

    Patients

    Seq Age Sex Outcome Treatment
    1