BEUDAMED
    FDA Adverse Event Summary report: N

    CORFLEX KNEE IMMOBILIZERS

    MDR report key: 2858037 · Received December 3, 2012

    Report

    Report Number
    MW5027926
    Date Received
    December 3, 2012
    Date of Event
    July 1, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CORFLEX UNIVERSAL
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED ON BEHALF OF HIS (B)(6) DAUGHTER REGARDING CORFLEX KNEE IMMOBILIZERS. THE REPORTER STATED HIS DAUGHTER WAS PRESCRIBED KNEE BRACES TO KEEP HER FEET AND KNEES FROM TURNING INWARD. HE EXPLAINED THE KNEE BRACES WERE TO BE WORN AT NIGHT. THE REPORTER STATED THE STEEL BARS THAT ARE IN THE PADS ON THE KNEE BRACES FALL OUT DAILY. THE REPORTER STATED HIS DAUGHTER HAS BEEN WEARING THE KNEE BRACES FOR APPROXIMATELY 6 MONTHS, BUT THE STEEL BARS ARE CONSTANTLY FALLING OUT AND POSE A VERY SERIOUS POTENTIAL THREAT TO THE CHILD'S SAFETY. HE SAID HE HAS TRIED MULTIPLE TIMES TO REACH THE MANUFACTURER AND HAS SENT THEM PICTURES OF THE BRACES COMING APART, BUT HAS NOT RECEIVED A RESPONSE FROM THEM. THE STEEL BARS THAT KEEP FALLING OUT ARE ABOUT 6-7 INCHES LONG, AND ABOUT 1 INCH WIDE. HE SAID HE HAS FOUND THE BARS IN THE CHILD'S BED AND UNDER THE BED. HE ALSO STATED THE STEEL BARS HAVE RIPPED THROUGH THE OUTER MATERIAL OF THE PADS ON THE KNEE BRACES. THE REPORTER HAS PICTURES HE WOULD LIKE TO SUBMIT OF THE BRACES COMING APART. HE IS EXTREMELY CONCERNED AND UPSET THAT THIS CHILD COULD POTENTIALLY BE INJURED BY THE KNEE IMMOBILIZERS AND STEEL BARS THAT KEEP FALLING OUT OF THEM. HE WAS REFERRED TO FILE A REPORT WITH THE FDA BY (B)(6), UNDER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLEX KNEE IMMOBILIZERS KNEE/LEG BRACES IQI CORFLEX UNIVERSAL

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR