BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBOUND HRD

    MDR report key: 8030110 · Received November 1, 2018

    Report

    Report Number
    3005770977-2018-00008
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Report Date
    November 1, 2018
    Manufacturer
    ARB MEDICAL, LLC
    Product Code
    FTL
    PMA / PMN Number
    K063671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR (AN INITIAL REPORTER) REPORTED THAT THE BROKEN FRAME (RING) OF THE MESH OF REBOUND HRD WAS EXPLANTED AND THE MESH WAS LEFT INSIDE, SO AS TO KEEP THE HERNIA REPAIRED.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF PAIN. IT WAS REPORTED THAT THE FRAME (ALSO KNOWN AS A RING) OF THE MESH OF THE HERNIA REPAIR DEVICE, REBOUND HRD, WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868231 REBOUND HRD HERNIA REPAIR MESH FTL ARB MEDICAL, LLC RB-SLD-S-PP 160025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention