BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBOUND HRD

    MDR report key: 5288588 · Received December 9, 2015

    Report

    Report Number
    3005770977-2015-00006
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    March 25, 2012
    Report Date
    November 12, 2015
    Manufacturer
    ARB MEDICAL LLC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    MFR ESTIMATES THIS PROBLEM WAS OCCURRED IN APPROX .03% OF PTS RECEIVING THIS DEVICE EFFORTS TO REDUCE ITS OCCURRENCE ARE CONTINUING. THIS MDR FILLING IS BEYOND THE 30 DAY REPORTING TIME BECAUSE OUR INITIAL INVESTIGATION DEEMED THE INCIDENT WAS NOT REPORTABLE. WE INITIALLY CONCLUDED THAT THE SURGICAL INTERVENTION WAS NOT PERFORMED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THIS EVENT IS BEING REPORTED AT THIS TIME AS A RESULT OF A RECENT FDA INSPECTION OF OUR MFG FACILITY WHERE THE FDA REPRESENTATIVE OBSERVED THIS EVENT TO BE REPORTABLE.

    Description of Event or Problem · 1

    PT REPORTED SOME PAIN AND DISCOMFORT AFTER IMPLANTATION. THE DEVICE WAS REMOVED FROM THE PT. DURING THE SURGICAL REMOVAL, IT WAS OBSERVED THE DEVICE HAD A SEPARATION OF THE NITINOL FRAME COMPONENT OF THE DEVICE. THE DEVICE EVAL REVEALED SURFACE IRREGULARITIES AND CABLE SEPARATION CAUSED BY FATIGUE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808508 REBOUND HRD HERNIA REPAIR DEVICE FTL ARB MEDICAL LLC RB-OVL-M-PTFE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other