BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN OTOLOGIC REPAIR GRAFT

    MDR report key: 7183410 · Received January 11, 2018

    Report

    Report Number
    1835959-2018-00001
    Event Type
    Injury
    Date Received
    January 11, 2018
    Report Date
    January 11, 2018
    Manufacturer
    COOK BIOTECH
    Product Code
    KHJ
    UDI-DI
    10827002448398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MFG NARRATIVE-NOTES DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT, 510(K) K161000 PREVIOUSLY K150594. A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DOCUMENTED NON-CONFORMANCE WOULD NOT HAVE CONTRIBUTED TO THE REPORTED FEEDBACK. A TOTAL OF TEN (10) DEVICES WAS PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS ASSOCIATED WITH THE REPORTED LOT NUMBER. A REVIEW OF THE IFU REVEALED THAT PERFORATION AND RECURRENCE ARE AMONGST THE LIST OF POTENTIAL COMPLICATIONS THAT "ARE POSSIBLE WITH THE USE OF SURGICAL DEVICE MATERIALS IN OTOLOGIC PROCEDURES." A DIRECT ROOT CAUSE, TO THE REPORTED PERFORATION PERSISTENCE AND INCREASE IN SIZE, IS INCONCLUSIVE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED OUTCOME INCLUDE: PATIENT¿S OVERALL HEALTH, LACK OF VIABLE TISSUE IN AREA BEING TREATED, INADEQUATE BLOOD SUPPLY TO THE REPAIR, GRAFT TOO SMALL FOR DEFECT, USER TECHNIQUE, AND PATIENT POST-OPERATIVE CARE OF THE TREATED AREA AND OVERALL POST-OP PATIENT ACTIVITIES. THE REPORTED WORSENING OF THE PATIENT¿S HEARING IS A SECONDARY EFFECT OF THE PERFORATION PERSISTENCE AND/OR INCREASE IN SIZE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, DR. (B)(6) IMPLANTED AN ENT-OTO-0.6X0.9 FOR REPAIR OF A TYMPANIC MEMBRANE PERFORATION. THIS WAS A CLEAN AND DRY PROCEDURE. NO INFECTION WAS PRESENT AT THE TIME OF DEVICE PLACEMENT. THE PERFORATION WAS SMALL (UNDER 10%) AND CENTRALLY LOCATED. THE DEVICE WAS HYDRATED AND PLACED IN AN UNDERLAY FASHION. GELFOAM WAS PLACED IN THE MIDDLE EAR AND AN UNSPECIFIED OINTMENT WAS USED ON THE EXTERNAL EAR. THE TYMPANIC PERFORATION PERSISTED AND INCREASED IN SIZE. NO INFECTION WAS PRESENT, THE DEVICE DEGRADED / DID NOT REMODEL, BUT IT WAS NOT RETRIEVED. THE PATIENT'S HEARING REPORTEDLY WORSENED FROM THE PRE-OP STATE OF HEARING. THE SURGEON REPORTED THE PATIENT WILL NEED ANOTHER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26765 BIODESIGN OTOLOGIC REPAIR GRAFT OTOLOGIC REPAIR GRAFT KHJ COOK BIOTECH G44839 10827002448398

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR GELFOAM AND OINTMENT