BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 19956482 · Received August 9, 2024

    Report

    Report Number
    9616086-2024-00055
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    June 29, 2024
    Report Date
    August 9, 2024
    Manufacturer
    DJO LLC
    Product Code
    KNP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE LINING UNDER RIGHT HALLUX WORE THROUGH AND CAUSED AN CALLUS WITH A LARGE WOUND UNDERNEATH THE CALLUS ON RIGHT HALLUX. PATIENT IS DIABETIC. PATIENT WENT TO HIS PODIATRIST, WHO CLEANED THE WOUND AND PROVIDED A DRESSING, AND RECOMMENDED TO STAY OFF THE FOOT AS MUCH AS POSSIBLE. PATIENT WAS NOT HOSPITALIZED. PODIATRIST IS CONCERNED AMPUTATION MAY BE REQUIRED. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE A SUPPLEMENTAL REPORT TO THIS DOCUMENT WILL BE PROVIDED.

    Description of Event or Problem · 0

    LINING UNDER RIGHT HALLUX WORE THROUGH AND CAUSED AN CALLUS WITH A LARGE WOUND UNDERNEATH THE CALLUS ON RIGHT HALLUX. PATIENT IS DIABETIC. PATIENT WENT TO HIS PODIATRIST, WHO CLEANED THE WOUND AND PROVIDED A DRESSING, AND RECOMMENDED TO STAY OFF THE FOOT AS MUCH AS POSSIBLE. PATIENT WAS NOT HOSPITALIZED. PODIATRIST IS CONCERNED AMPUTATION MAY BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205558 DR COMFORT RELAX CAMEL 12 WIDE KNP DJO LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other