BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBOUND HRD

    MDR report key: 7135334 · Received December 20, 2017

    Report

    Report Number
    3005770977-2017-00005
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    October 22, 2017
    Report Date
    November 23, 2017
    Manufacturer
    ARB MEDICAL, LLC
    Product Code
    FTL
    UDI-DI
    00892579001171
    PMA / PMN Number
    K063671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY AN X-RAY IMAGE OF THE BROKEN FRAME OF THE MESH OF THE HERNIA REPAIR DEVICE, REBOUND HRD (LOT NUMBER 160041) WAS SENT TO US (THE MANUFACTURER) BY THE DISTRIBUTOR WHO IS THE INITIAL REPORTER. NO MALFUNCTIONED DEVICE WAS RETURNED TO US (THE MANUFACTURER).

    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. THE PATIENT UNDERWENT SURGERY AND THE BROKEN FRAME WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912149 REBOUND HRD HERNIA REPAIR MESH FTL ARB MEDICAL, LLC RB-SLD-S-PP 160041 00892579001171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention