BEUDAMED
    FDA Adverse Event Summary report: N

    DR. SCHOLL'S CUSTOM FIT ORTHOTICS

    MDR report key: 2444618 · Received January 6, 2012

    Report

    Report Number
    1031623-2011-55596
    Date Received
    January 6, 2012
    Report Date
    December 1, 2011
    Manufacturer
    SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) SPONTANEOUS REPORT WAS RECEIVED FROM A MALE CONSUMER. AGE NOT PROVIDED. INITIALS ANONYMIZED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT PROVIDED. DR. SCHOLL'S CUSTOM FIT ORTHOTICS, CP440 USED FOR "MAKING MY FEET MORE COMFORTABLE." THERAPY DATES NOT PROVIDED. THE CONSUMER REPORTED THAT THE DR. SCHOLL'S CUSTOM FIT ORTHOTICS WERE INEFFECTIVE AND HE REPORTED "THEY HAVE LEFT THE BIG TOES IN BOTH OF MY FEET PERMANENTLY WITHOUT SENSATION," AND CAUSED "PERMANENT NERVE DAMAGE." HE STATED "THE LOSS OF SENSATION IN MY TOES WAS DIRECTLY RELATED TO USING THE INSERTS." HE ALSO STATED THAT HE WAS IN THE PROCESS OF SEEING SEVERAL PODIATRISTS AND ORTHOPEDIC DOCTORS IN HOPES OF REGAINING "THE FEELING" IN HIS TOES. OUTCOME NOT RECOVERED/ NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DR. SCHOLL'S CUSTOM FIT ORTHOTICS NONE KNP SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other