BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE IMMOB.BLUE CNVS 22" MEDIU

    MDR report key: 417819 · Received September 18, 2002

    Report

    Report Number
    1037420-2002-00013
    Event Type
    Injury
    Date Received
    September 18, 2002
    Report Date
    September 11, 2002
    Manufacturer
    DEROYAL INDUSTRIES, INC
    Product Code
    ITQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE END OF THE STAY POCKET AT THE BOTTOM OF THE IMMOBILIZER WAS NOT SEWN. THE BINDING GOES AROUND THE KNEE BODY BUT DID NOT CATCH THE STAY POCKET. THE STAY CAME OUT OF THE IMMOBILIZER AND HIT THE BRICK STEPS AS THE PATIENT WAS WALKING AND CAUSED THEM TO FALL AND DISLOCATE THEIR KNEE AGAIN. PT WAS PUT INTO THIS BRACE AT THE HOSPITAL LAST WEEKEND AFTER THEY DISLOCATED THEIR KNEE. REPORTER DESCRIBED THE PRODUCT AS BLUE WITH WHITE BINDING, THE PRODUCT NUMBER ON THIS REPORT MAY NOT BE CORRECT. CO WILL HAVE UPS PICK UP THE BRACE FOR RETURN TO THE CO AND WILL CHANGE THE PRODUCT NUMBER WHEN CO DETERMINES WHAT THE PRODUCT IS. REPLACEMENT OF 1020227 WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNEE IMMOB.BLUE CNVS 22" MEDIU BLC BLUE LINE KNEE PRODUCTS ITQ DEROYAL INDUSTRIES, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention