BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L5000 TOE FILLER CUSTOM INSOLE

    MDR report key: 19265624 · Received May 7, 2024

    Report

    Report Number
    9616086-2024-00035
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 7, 2024
    Manufacturer
    DJO LLC
    Product Code
    KYS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TOE FILLER CAUSED A SORE ON THE PATIENTS STUMP AROUND THE 2ND AND 3RD METATARSAL BONE. IT IS UNKNOWN HOW LONG THE TOE FILLER WAS USED BEFORE THE SORE OCCURED. PATIENT DID RECEIVE MEDICAL TREATMENT AT A MEDICAL FACILITY, HE HAD SOME DRESSING DONE FOR ABOUT 1 MONTH. THE SORE IS NOW HEALED CUSTOMER DISCARDED THE TOE FILLER SINCE IT HAD BODILY FLUIDS FROM THE OPEN SORE. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOE FILLER CAUSED A SORE ON THE PATIENTS STUMP AROUND THE 2ND AND 3RD METATARSAL BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100662 L5000 TOE FILLER CUSTOM INSOLE INSOLES, MEDICAL KYS DJO LLC 17-0004-0-00000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other