BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR. SCHOLL'S CUSTOM FIT ORTHOTICS

    MDR report key: 2720242 · Received June 7, 2010

    Report

    Report Number
    1031623-2010-23855
    Event Type
    Injury
    Date Received
    June 7, 2010
    Report Date
    May 5, 2010
    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 US SPONTANEOUS REPORT FROM A FEMALE CONSUMER. AGE NOT PROVIDED, INITIALS ANONYMIZED. MEDICAL HISTORY, CONCOMITANT MEDICATIONS WERE NOT PROVIDED. PRODUCT USE REPORTED AS DR (B)(6) CUSTOM FIT ORTHOTICS. DATES OF USE, FREQUENCY AND INDICATION FOR USE WERE NOT PROVIDED. THE CONSUMER REPORTED "IT BROKE MY FOOT" NO OTHER INFO WAS PROVIDED.

    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