BEUDAMED
    FDA Adverse Event Other Summary report: N

    DR. SCHOLL'S CUSTOM FIT ORTHOTICS

    MDR report key: 2640464 · Received June 27, 2012

    Report

    Report Number
    1031623-2012-00005
    Event Type
    Other
    Date Received
    June 27, 2012
    Date of Event
    October 10, 2010
    Report Date
    June 26, 2012
    Manufacturer
    SCHERING-PLOUGH HEALTH CARE PRODUCTS
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A UNITED STATES SERIOUS SPONTANEOUS REPORT WAS RECEIVED FROM THE CONSUMER PRODUCT SAFETY COMMISSION (B)(4) REGARDING A (B)(6) MALE CONSUMER. RACE AND INITIALS NOT PROVIDED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT PROVIDED. DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF440 WERE WORN FOR SORE FEET, THERAPY DATES NOT PROVIDED. A CONSUMER REPORTED TO CPSC THAT HE "BOUGHT SOME DR. SCHOLL INSERTS PER THEIR RECOMMENDATION" (ESTIMATED PURCHASE DATE (B)(6) 2010). HE STATED THAT "WITHIN A FEW DAYS ((B)(6) 2010) I BROKE MY NAVICULAR BONE FROM THE STRESS CAUSED BY THEM. MY FOOT WAS SORE PRECEDING AND XRAYS WERE TAKEN WITH NO BREAKS. DR. RECOMMENDED AN INSERT SO I BOUGHT, BUT AFTER WEARING THEM A FEW DAYS I FELT A SNAP, SURE ENOUGH I HAD BROKEN A BONE; NAVICULAR BONE WAS PINCHED BY THE STRESS CAUSED BY THESE INSOLES, CONFIRMED BY XRAY." HE STATED THAT IT HAD "NEVER HEALED CORRECTLY" AND "HAD BEEN BROKEN AGAIN." HE REPORTED THAT IT NOW REQUIRED SURGERY TO FIX IT. OUTCOME UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other