BEUDAMED
    FDA Adverse Event Other Summary report: N

    DR. SCHOLL'S CUSTOM FIT ORTHOTICS

    MDR report key: 2593863 · Received May 25, 2012

    Report

    Report Number
    1031623-2012-00004
    Event Type
    Other
    Date Received
    May 25, 2012
    Report Date
    May 25, 2012
    Manufacturer
    SCHERING-PLOUGH HEALTHCARE PRODUCTS
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DECHALLANCE/RECHALLANCE NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    A SERIOUS U.S. SPONTANEOUS REPORT FROM A MALE CONSUMER, AGE NOT PROVIDED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. DR. SCHOLL'S CUSTOM FIT ORTHOTICS (NO ACTIVE INGREDIENTS) WERE PURCHASED "ABOUT 2 OR 3 MONTHS AGO. I STARTED WEARING THEM" DATES OF PRODUCT USE AND INDICATION FOR USE WERE NOT PROVIDED. THE CONSUMER REPORTED HE "HAD A HIP OPERATION NOT THAT LONG AGO. ABOUT THREE WEEKS AGO I EXPERIENCED EXCRUCIATING PAIN IN MY LEFT FOOT AND MY TOE AREA." THE CONSUMER WAS SEEN BY TWO ORTHOPEDIC SURGEONS, XRAYS WERE DONE ("THEY WANTED TO DO A MRI") AND HE WAS DIAGNOSED WITH STRESS FRACTURES OF THE LEFT FOOT. HE REPORTED HE HAS "TO WEAR A BOOT FOR 6-8 WEEKS AND CAN NOT WALK. I JUST STARTED TO WALK ABOUT THREE WEEKS AGO AFTER I HAD MY HIP SURGERY, NOW THEY WANT ME BACK OFF OF MY FEET FOR 6-8 WEEKS WITH THIS STRESS FRACTURE." "THIS PRODUCT TAKES THE STRESS OFF THE ANKLE AND PUTS IT ON THE TOES AND I THINK THAT IS HOW I DEVELOPED THESE FRACTURES. I NOW HAVE DOCTOR BILLS AND PAIN AND SUFFERING I HAVE TO UNDERTAKE." THE CONSUMER REPORTED "I REALIZE THOUGH THAT I DO HAVE AN ANKLE PROBLEM THAT WILL NEVER HEAL."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other