BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 7670309 · Received July 9, 2018

    Report

    Report Number
    3008579854-2018-00007
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 9, 2018
    Manufacturer
    DR COMFORT, A DJO, LLC COMPANY
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGES "PATIENT EXPERIENCED STAPH INFECTION BECAUSE THE INSERT IS AN INCH SMALLER THAN THE SHOES"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511479 DR COMFORT K0903 SPECIAL ACCOMM CUSTOM INSOLES KYS DR COMFORT, A DJO, LLC COMPANY 17-0002-0-00000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other