BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE SUPPORT, W/ BUTTRESS, MED/LAT STAYS, XL

    MDR report key: 3812565 · Received April 17, 2014

    Report

    Report Number
    1123071-2014-00006
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 17, 2014
    Manufacturer
    DEROYAL INDUSTRIAL
    Product Code
    IQI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE COMPLAINT SAMPLE WAS RETURNED. UPON OPENING THE BOXES, THE ONLY SMELL I NOTED IS THE SMELL OF THE NEOPRENE AND THE CHEMICALS (B-FOAM AND CR ADHESIVE) THAT THE MATERIAL IS MADE OF. IT IS NORMAL FOR NEOPRENE TO HAVE A "SMELL." THIS APPEARS TO HAVE BEEN AN IRRITANT TO THE CUSTOMER'S ASTHMA ISSUES. I HAVE ATTACHED AN EMAIL FROM THE CUSTOMER REGARDING THE COMPLAINT AND ISSUES REPORTED BY THEIR CUSTOMER. CORRECTION: CREDIT REQUESTED. ROOT CAUSE ANALYSIS: THE CUSTOMER'S SENSITIVITY TO THE MATERIALS USED TO MAKE NEOPRENE HAVE CREATED AN EYE/BREATHING IRRITANT. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: NO ACTION REQUIRED AT THIS TIME, NO MANUFACTURING ISSUE WAS FOUND. THE COMPLAINT IS RELATED TO THE CUSTOMER'S PERSONAL SENSITIVITIES.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE BRACES HAVE A VERY STRONG ODOR THAT IS AFFECTING HER ASTHMA SO SHE CAN'T WEAR THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236018 KNEE SUPPORT, W/ BUTTRESS, MED/LAT STAYS, XL IQI DEROYAL INDUSTRIAL 35423214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention