BEUDAMED
    FDA Adverse Event Summary report: N

    DR. SCHOLL'S CUSTOM FIT ORTHOTICS

    MDR report key: 2894093 · Received March 9, 2012

    Report

    Report Number
    1031623-2012-11369
    Date Received
    March 9, 2012
    Report Date
    March 8, 2012
    Manufacturer
    SCHERING-PLOUGH CORP
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SERIOUS U.S SPONTANEOUS REPORT RECEIVED REGARDING A FEMALE CONSUMER. AGE NOT PROVIDED AND INITIALS ANONYMIZED. MEDICAL HISTORY AND CONCOMITANT MEDICATION NOT PROVIDED. DR SCHOLL'S CUSTOM FIT ORTHOTICS (B)(4) WERE WORN FOR AN UNK INDICATION. THERAPY DATES NOT SPECIFIED. CONSUMER REPORTED THAT SHORTLY AFTER PURCHASE OF DR SCHOLL'S CUSTOM FIT ORTHOTICS, SHE EXPERIENCED A "FRACTURED THIRD METATARSAL IN RIGHT FOOT AND UNDERWENT TREATMENT FOR NEARLY TWO MONTHS." AFTER RETURNING TO NORMAL ACTIVITY, SHE REPORTED THE ORTHOTICS TO BE UNCOMFORTABLE AND CAUSED HER INJURED FOOT TO ACHE WHEN SHOES WERE REMOVED. OUTCOME: RECOVERED/RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other