BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L5000 TOE FILLER CUSTOM INSOLE

    MDR report key: 19177646 · Received April 24, 2024

    Report

    Report Number
    9616086-2024-00034
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    August 10, 2023
    Report Date
    April 24, 2024
    Manufacturer
    DJO LLC
    Product Code
    KYS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WAS A HARD SPOT ON THE ORTHOTIC THAT CAUSED OPEN WOUND. THE PATIENT WAS TREATED FOR THE WOUND WITH DEBRIDEMENT AND ROUTINE DRESSING CHANGES. THE RETURNED PRODUCT INSPECTED AND COMPLAINT WAS CONFIRMED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HARD SPOT ON THE ORTHOTIC THAT CAUSED OPEN WOUND. THE PATIENT WAS TREATED FOR THE WOUND WITH DEBRIDEMENT AND ROUTINE DRESSING CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605808 L5000 TOE FILLER CUSTOM INSOLE INSOLES, MEDICAL KYS DJO LLC 17-0004-0-00000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other