BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOUND HRD-V

    MDR report key: 7324787 · Received March 8, 2018

    Report

    Report Number
    3005770977-2018-00004
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ARB MEDICAL, LLC
    Product Code
    FTL
    PMA / PMN Number
    K083467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTIONED DEVICE WAS RETURNED TO US (THE MANUFACTURER), BUT A PICTURE OF THE EXPLANTED MALFUNCTIONED RING WAS PROVIDED TO US (THE MANUFACTURER).

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF PAIN. THE PICTURE OF THE EXPLANTED FRAME (ALSO KNOWN AS THE NITINOL RING) OF THE MESH OF THE HERNIA REPAIR DEVICE, REBOUND HRD-V, SHOWED THAT THE RING WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166267 REBOUND HRD-V HERNIA REPAIR MESH FTL ARB MEDICAL, LLC RB-OVL-L-PTFE 090087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention