BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT GSA WINNER BLACK 11.5 XWIDE

    MDR report key: 8699369 · Received June 14, 2019

    Report

    Report Number
    3008579854-2019-00007
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 13, 2019
    Manufacturer
    DR. COMFORT, A DJO, LLC COMPANY
    Product Code
    KNP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE SHOE WAS RUBBING ON TOP FOOT CAUSED CUT AND INFECTION". FURTHER INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492643 DR COMFORT GSA WINNER BLACK 11.5 XWIDE ORTHOSIS, CORRECTIVE SHOE KNP DR. COMFORT, A DJO, LLC COMPANY 5710-X-11.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention