BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 22722969 · Received August 5, 2025

    Report

    Report Number
    9616086-2025-00055
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    February 17, 2025
    Report Date
    August 5, 2025
    Manufacturer
    DJO LLC
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT CLAIMS HEEL IS TOO HIGH CAUSING WEIGHT FORWARD AND PRESURE ON BALL OF FOOT CAUSING BLISTERS AND OPEN WOUND THAT REQUIRED MEDICAL TREATMENT. THE CUSTOM INSOLE WAS RETURNED FOR EVALUATION; CUSTOM INSERTS FOUND NO DEFECT. CUSTOMS WERE MADE TO SPECIFICATION. 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 PATIENT CLAIMS HEEL IS TOO HIGH CAUSING WEIGHT FORWARD AND PRESURE ON BALL OF FOOTM CAUSING BLISTERS AND OPEN WOUND THAT REQUIRED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377853 DR COMFORT A5514 REGULAR ACCOMM CUSTOM INSOLES KYS DJO LLC 14370928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other