BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN OTOLOGIC REPAIR GRAFT

    MDR report key: 9188094 · Received October 14, 2019

    Report

    Report Number
    1835959-2019-00004
    Event Type
    Injury
    Date Received
    October 14, 2019
    Report Date
    October 9, 2019
    Manufacturer
    COOK BIOTECH
    Product Code
    KHJ
    UDI-DI
    10827002444512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNSPECIFIED BY THE COMPLAINANT. 510(K): K161000. NO EVALUATION CODE DESC: NO DEVICE WAS RETURNED TO THE MANUFACTURER. DEVICE MAY HAVE BEEN PARTIALLY EXPLANTED AND DISCARDED OR SUBMITTED TO PATHOLOGY. SOME PORTION OF THE DEVICE REMAINED IMPLANTED IN THE PATIENT. INVESTIGATION INTO THIS FEEDBACK INCLUDED: A REVIEW OF THE FEEDBACK DETAILS, A REVIEW OF THE DEVICE LOT HISTORY RECORD, A REVIEW OF THE CBI COMPLAINT DATABASE, AND A REVIEW OF THE BIODESIGN OTOLOGIC REPAIR GRAFT IFU FP0108-01. NO DEVICE WAS RETURNED TO THE MANUFACTURER. DEVICE MAY HAVE BEEN PARTIALLY EXPLANTED AND DISCARDED OR SUBMITTED TO PATHOLOGY. SOME PORTION OF THE DEVICE REMAINED IMPLANTED IN THE PATIENT. A REVIEW OFT HE DEVICE LOT HISTORY RECORD REVEALED THERE WERE NO NONCONFORMANCES OR DEVIATIONS ASSOCIATE WITH THE LOT. THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. A QUANTITY OF TEN (10) DEVICE WAS PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVIEW ANY ADDITIONAL COMPLAINTS ASSOCIATED WITH THE REPORTED LOT NUMBER. THE IFU DOES NOTE INFLAMMATION, CHOLESTEATOMA, SQUAMOUS CYSTS, AND THICKENING OF THE TYMPANIC MEMBRANE AMONGST THE LIST OF POTENTIAL COMPLICATIONS. THE ROOT CAUSE, OF THE POSSIBLE REACTION TO THE GRAFT, IS INCONCLUSIVE. THE PATHOLOGY RESULTS WERE NOT PROVIDED TO THE MANUFACTURER AND THEREFORE A POSSIBLE REACTION TO THE GRAFT CAN NEITHER BE CONFIRMED NOR RULED OUT. PROCEDURE SPECIFIC DETAILS WERE ALSO NOT PROVIDED TO THE MANUFACTURER. IT IS UNKNOWN WHAT ADDITIONAL DEVICES, PRODUCTS, OR MEDICATIONS WERE USED DURING THE INITIAL SURGERY. DETAILS RELATING TO THE SURGEONS TECHNIQUE WERE ALSO NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2019, DR. (B)(6) IMPLANTED A BIODESIGN OTOLOGIC REPAIR GRAFT FOR A RIGHT TYMPANOPLASTY. AT AN UNSPECIFIED TIME POST OP, THE PATIENT WAS BELIEVED TO HAVE HAD A REACTION TO THE GRAFT IN WHICH A MASS WAS PRESENT. THE MASS WAS IN THE EXTERNAL AUDITORY CANAL (EAC) TO THE MIDDLE EAR. THE PATIENT UNDERWENT AN EXPLORATORY TYMPANOPLASTY FOR REMOVAL OF THE MASS. THE MASS WAS SENT TO PATHOLOGY. THE GRAFT WAS NOT REMOVED IN FULL AS DOING SO WOULD HAVE RESULTED IN A PARTIAL EAR CANAL AND EAR DRUM RESECTION. THE PATIENT WAS TREATED WITH CIPRODEX (ANTIBIOTIC) PACKING. THE PATHOLOGY WAS REPORTEDLY CONSISTENT WITH A POSSIBLE REACTION TO THE GRAFT. HOWEVER, PATHOLOGY RESULTS WERE NOT AVAILABLE TO THE GRAFT MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983019 BIODESIGN OTOLOGIC REPAIR GRAFT OTOLOGIC REPAIR GRAFT KHJ COOK BIOTECH G44451 LB1095593 10827002444512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention