BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOUND HRD

    MDR report key: 7134067 · Received December 20, 2017

    Report

    Report Number
    3005770977-2017-00010
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    October 5, 2017
    Report Date
    November 20, 2017
    Manufacturer
    ARB MEDICAL, LLC
    Product Code
    FTL
    UDI-DI
    00892579001171
    PMA / PMN Number
    K063671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTIONED DEVICE WAS RETURNED TO US (THE MANUFACTURER), AND NO X-RAY IMAGE OF THE IMPLANTED MALFUNCTIONED DEVICE WAS PROVIDED TO US (THE MANUFACTURER).

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF PAIN. THE COMPLAINT MENTIONED THAT AN X-RAY IMAGE SHOWED THE FRAME (ALSO KNOWN AS THE NITINOL RING) OF THE MESH OF THE HERNIA REPAIR DEVICE, REBOUND HRD, WAS BROKEN, THAT THE RING WAS PARTIALLY WITHDRAWN IN THE AIM TO DECREASE THE PAIN., AND THAT THE BREAKAGE DID NOT HAPPEN AT THE WELD OF THE RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914603 REBOUND HRD HERNIA REPAIR MESH FTL ARB MEDICAL, LLC RB-SLD-S-PP 160007 00892579001171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention