BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELITA-SPON/INVOTEC FINAL

    MDR report key: 2130421 · Received June 13, 2011

    Report

    Report Number
    3005759666-2011-00001
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    GELITA MEDICAL B.V.
    Product Code
    KHJ
    PMA / PMN Number
    K051911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # R00008/1. ROOT CAUSE OF FAILURE: AT THIS TIME, NO REASON CAN BE FOUND AS TO WHY THE DEVICE(S) SHOULD HAVE FAILED TO PERFORM AS INTENDED FOR USE AS ADHESION BARRIERS. GELITA MEDICAL NOTES THAT ALL THREE REPORTS ARE FROM ONE SURGEON AT ONE HEALTHCARE FACILITY. SURGEON HAS INDICATED THAT THEY HAVE BEEN SATISFIED WITH THE PERFORMANCE OF THIS DEVICE IN THE PAST AND WILL USE THIS DEVICE IN THE FUTURE. GELITA MEDICAL WILL CONTINUE TO MONITOR FAILURE RATES FOR THIS PARTICULAR ADVERSE EVENT IN THIS INDICATION AND FOR THESE LOT NUMBERS IN PARTICULAR.

    Description of Event or Problem · 1

    A FEMALE IN HER (B)(6) PRESENTING WITH FACIAL PAIN AND SINUS POLYP WAS TREATED AT (B)(6), USING GELITA-SPON/INVOTEC FINAL AS AN ENT ADHESION BARRIER. AT THREE WEEKS POST-OP FOLLOW-UP, THE PATIENT WAS FOUND TO HAVE DEVELOPED ADHESIONS BETWEEN THE MIDDLE TURBINATE AND LATERAL NASAL WALL. PATIENT WILL RETURN TO THE OPERATING ROOM FOR REVISION AND DIVISION OF THESE ADHESIONS. THE SAME SURGEON REPORTS A FURTHER TWO (RECENT) CASES OF ADHESIONS AFTER MIDDLE MEATAL ANTROSTOMIES AND ETHMOIDECTOMY. FOR THESE TWO EVENTS, NO FURTHER PATIENT DETAILS, EVENT DETAILS OR PATIENT OUTCOMES WERE PROVIDED BY THE SURGEON WHEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELITA-SPON/INVOTEC FINAL ABSORBABLE GELATIN SPONGE KHJ GELITA MEDICAL B.V. AS BRAND R00010/1

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention