BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 22620381 · Received July 25, 2025

    Report

    Report Number
    9616086-2025-00054
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 25, 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 PAIR OF CUSTOM INSERTS FROM (B)(6) 2024 CAUSED A WOUND THAT EQUIRED MEDICAL TREATMENT. THE CUSTOM INSOLE WAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT IF MORE INFORMARTION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PAIR OF CUSTOM INSERTS FROM (B)(6) 2024 CAUSED A WOUND THAT EQUIRED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287619 DR COMFORT L5000 TOE FILLER CUSTOM INSOLE KYS DJO LLC 14238693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other