BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L5000 TOE FILLER CUSTOM INSOLE

    MDR report key: 16301459 · Received February 4, 2023

    Report

    Report Number
    9616086-2023-00003
    Event Type
    Injury
    Date Received
    February 4, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 10, 2023
    Manufacturer
    DJO LLC
    Product Code
    KYS
    PMA / PMN Number
    EXEMPT
    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 ALLEGEDLY INSERT DOES NOT PROVIDE FULL CONTACT WITH PATIENTS TOE THAT CAUSED A ULCER. MEDICAL INTERVENTION WAS REQUIRED, IT WAS REPORTED BY THE DOCTOR THE MEDICAL TREATMENT THAT WAS PROVIDED WAS DEBRIDEMENT OF ULCERATIONS, OFFLOADING, AND APPLICATIONS OF SKIN GRAFT SUBSTITUTE. THE TOE FILLER AND SHOES WERE RETURNED TO ENOVIS FOR EVALUATION. THE INVESTIGATION FOUND THAT THERE WAS NO DEFECT FOUND WITH THE SHOES AND THE INVESTIGARTION WITH TOE FILLERS FOUND THAT THE TOE FILLER WAS MIS ASSEMBLED 3/8 OF SPACE FROM FILLER TO AMP SITE WAS NOT INCLUDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALLEGEDLY INSERT DOES NOT PROVIDE FULL CONTACT WITH PATIENTS TOE THAT CAUSED A ULCER, THE PATIENT DID SEEK MEDICAL ATTENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326686 L5000 TOE FILLER CUSTOM INSOLE INSOLES, MEDICAL KYS DJO LLC 17-0004-0-00000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other 3470-M-07.0 LOT: UNKNOWN