BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOUND HRD

    MDR report key: 7121509 · Received December 15, 2017

    Report

    Report Number
    3005770977-2017-00004
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ARB MEDICAL, LLC
    Product Code
    FTL
    PMA / PMN Number
    K063671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PICTURE AND X-RAY IMAGES OF THE EXPLANTED BROKEN FRAME OF THE MESH OF THE HERNIA REPAIR DEVICE, REBOUND HRD (LOT NUMBER 140015) WERE SENT TO US (THE MANUFACTURER) BY THE DISTRIBUTOR WHO IS THE INITIAL REPORTER. NO MALFUNCTIONED DEVICE WAS RETURNED TO US.

    Description of Event or Problem · 1

    THE FRAME (ALSO KNOWN AS THE RING) OF THE MESH OF THE IMPLANTED HERNIA REPAIR DEVICE (REBOUND HRD) BROKE. IT CAUSED AN INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901559 REBOUND HRD HERNIA REPAIR MESH FTL ARB MEDICAL, LLC RB-SLD-S-PP 140015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention