BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 22620387 · Received July 25, 2025

    Report

    Report Number
    9616086-2025-00056
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 25, 2025
    Manufacturer
    DJO LLC
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT WORE THE SHOES AND INSERTS FOR ABOUT A WEEK AND STARTED NOTICING A FOUL SMELL AND DRAINAGE FROM RIGHT FOOT PATIENT WENT BACK TO THE PROVIDER TO RECEIVE TREATMENT FOR THE ULCER. THE CUSTOM INSOLE WAS RETURNED FOR EVALUATION; EVALUATION OF CUSTOM INSERT FOUND NO DEFECT. MADE TO PATIENT SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE ESTABLISHED. 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 WORE THE SHOES AND INSERTS FOR ABOUT A WEEK AND STARTED NOTICING A FOUL SMELL AND DRAINAGE FROM RIGHT FOOT. PATIENT WENT BACK TO THE PROVIDER TO RECEIVE TREATMENT FOR THE ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287625 DR COMFORT A5514 REGULAR ACCOMM CUSTOM INSOLES KYS DJO LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other