BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 23176263 · Received September 29, 2025

    Report

    Report Number
    9616086-2025-00064
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 29, 2025
    Manufacturer
    DJO LLC
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE INSERT WITH THE TOE FILLER WAS A BIT DIFFERENT THAN THE ONE HE HAD. THE PATIENT WAS COMPLAINING THAT HIS FOOT WAS BLEEDING FROM THE INSERT. NO MEDICAL TREATMENT WAS PROVIDED PATIENT TREATED HIMSELF AT HOME. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE EVALUATION OF THE PHOTO SHOWS THE TOE FILLER IS NOT MADE THE SAME AS THE LAST ONE. THE ROOT CAUSE COULD HAVE BEEN DUE A MANUFACTURING PROCESS PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERT WITH THE TOE FILLER WAS A BIT DIFFERENT THAN THE ONE HE HAD. THE PATIENT WAS COMPLAINING THAT HIS FOOT WAS BLEEDING FROM THE INSERT. NO MEDICAL TREATMENT WAS PROVIDED PATIENT TREATED HIMSELF AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146378 DR COMFORT L5000 TOE FILLER CUSTOM INSOLE KYS DJO LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other