BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBOUND HRD

    MDR report key: 6482067 · Received April 11, 2017

    Report

    Report Number
    3005770977-2017-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 21, 2017
    Report Date
    March 28, 2017
    Manufacturer
    ARB MEDICAL, LLC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SEPARATED FRAME OF THE DEVICE WAS EXPLANTED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266123 REBOUND HRD HERNIA REPAIR DEVICE FTL ARB MEDICAL, LLC RB-SLD-S-PP 120061

    Patients

    Seq Age Sex Outcome Treatment
    1 Other