BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 25107491 · Received May 6, 2026

    Report

    Report Number
    9616086-2026-00018
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 6, 2026
    Manufacturer
    DJO LLC
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARBON PLATE IS NOT WITH THE SHOE AND THE FILLER MODIFICATIONS ARE TOO AGGRESSIVE EVEN WITH MODIFYING THE FILLER. NEEDS LESS AGGRESSIVE PUSH AGAINST THE FOOT CAUSING THE SORE TO REOPEN. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, COMPLAINT COULD NOT BE CONFIRMED, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARBON PLATE IS NOT WITH THE SHOE AND THE FILLER MODIFICATIONS ARE TOO AGGRESSIVE EVEN WITH MODIFYING THE FILLER. NEEDS LESS AGGRESSIVE PUSH AGAINST THE FOOT CAUSING THE SORE TO REOPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515034 DR COMFORT L5000 TOE FILLER CUSTOM INSOLE KYS DJO LLC 15077760

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 17-0004-0-00000 LOT: 15077760