BEUDAMED
    FDA Adverse Event Other Summary report: N

    DR. SCHOLL'S MASSAGING GEL HEEL CUPS

    MDR report key: 1883098 · Received July 14, 2010

    Report

    Report Number
    1031623-2010-00001
    Event Type
    Other
    Date Received
    July 14, 2010
    Report Date
    June 15, 2010
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(4) SERIOUS DEVICE REPORT WAS RECEIVED BY A COMPANY REPRESENTATIVE REGARDING A MALE CONSUMER. CONCOMITANT MEDICATIONS WERE UNKNOWN. MEDICAL HISTORY WAS NOT PROVIDED. THE COMPANY REPRESENTATIVE REPORTED THE CONSUMER'S WIFE HAD SPOKEN TO THE COMPANY REPRESENTATIVE'S WIFE AND STATED THE CONSUMER HAD USED (B)(4) MASSAGING GEL HEEL CUPS. FREQUENTLY OF USE AND INDICATION FOR PRODUCT USE WERE NOT PROVIDED. THE COMPANY REPRESENTATIVE STATED HE "GUESSED" THE PRODUCT HAD "CAUSED SOME BLISTER ON HIS FOOT" WHICH "BECAME INFECTED". HE ADDITIONALLY STATED THE CONSUMER EVENTUALLY HAD A TOE AMPUTATED. THE COMPANY REPRESENTATIVE WAS NOT SURE IF THIS WAS A DIRECT CAUSE AND EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DR. SCHOLL'S MASSAGING GEL HEEL CUPS ORTHOSIS, CORRECTIVE SHOE KYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other