BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 24761066 · Received April 1, 2026

    Report

    Report Number
    9616086-2026-00008
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 1, 2026
    Manufacturer
    DJO LLC
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CUSTOM INSOLE WAS RUBBING ON 5TH DIGIT METATARSAL PAS RESULTING IN INJURY AND AMPUTATION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, COMPLAINT COULD NOT BE CONFIRMED, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOM INSOLE WAS RUBBING ON 5TH DIGIT METATARSAL PAS RESULTING IN INJURY AND AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811705 DR COMFORT L5000 TOE FILLER CUSTOM INSOLE KYS DJO LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization 17-0004-0-00000 LOT: UNKNOWN