BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 21905966 · Received April 24, 2025

    Report

    Report Number
    9616086-2025-00042
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 24, 2025
    Manufacturer
    DJO LLC
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ULCER/PAIN. THE CUSTOM INSOLE WAS RETURNED FOR EVALUATION; A GAP FOUND ON THE INSERT COMPARED TO THE CLONE. THE ROOT CAUSE COULD HAVE BEEN DUE TO FIT ISSUE AND RUBBING. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ULCER/PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476184 DR COMFORT L5000 TOE FILLER CUSTOM INSOLE KYS DJO LLC 2410099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other