BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLA ORTHOPEDICS INC'S WORK ABOUT CARPOL MATE.

    MDR report key: 655818 · Received December 21, 2005

    Report

    Report Number
    MW1037252
    Event Type
    Malfunction
    Date Received
    December 21, 2005
    Date of Event
    December 10, 2005
    Report Date
    December 13, 2005
    Manufacturer
    FLA ORTHOPEDICS INC.
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CLIENT DEVELOPED BRIGHT REDNESS AND SEVERE EDEMA OF THE WRIST SHE WORE IT ON. SHE HAD A PERFECT OUTLINE ON HER SKIN OF HER WRIST OF WHERE SHE HAD WRIST SUPPORT TOUCHING HER SKIN. SPOUSE TELLS CO SHE IS NOT ALLERGIC TO LATEX ON METALS WHICH ARE ITEMS OF THE DEVICE ALONG WITH MATERIALS NOT PUBLISHED IN MANUFACTURER'S BROCHURE. CLIENT DID HAVE TO GO TO DR'S OFFICE FOR EVAL AND FURTHER MEDICAL TREATMENT AS ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLA ORTHOPEDICS INC'S WORK ABOUT CARPOL MATE. WRIST SUPPORT UNIVERSAL-BEIGE IOY FLA ORTHOPEDICS INC. 22-140UNBEG R14871A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other