BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCARE

    MDR report key: 20037459 · Received August 22, 2024

    Report

    Report Number
    9616086-2024-00057
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 19, 2023
    Report Date
    August 21, 2024
    Manufacturer
    DJO LLC
    Product Code
    KYS
    PMA / PMN Number
    E317265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ONE WEEK AFTER WEARING THE POST OP SHOE A SPOT UNDER SECOND TOE RIGHT FOOT. I RETURNED TO DR. EXAMINED THE SHOE AND SAW A PIECE OF METAL UNDER THE CUSHION WAS COMING THROUGH AND RUBBING MY FOOT. THE PATIENT IS DIABETIC, SO THE DR STARTED TREATING THE WOUND, AFTER 3 WEEKS HAD GOTTEN LARGER. THE PATIENT RECEIVED TREATMENT FOR ANOTHER 2 MONTHS TRYING TO GET THE WOUND TO HEAL. ON (B)(6) 2023, THE PATIENT WENT SEPTIC FROM THE WOUND ORAL ANTIBIOTICS WHERE NOT WORKING. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6), 2023, WHERE AFTER IV ANTIBIOTICS THEY DECIDED TO AMPUTATE THE PATIENTS TOE. THE PATIENT WENT HOME AND WAS READMITTED INTO THE HOSPITAL ON (B)(6)2023, TO REMOVE MORE BONE DUE TO NOT HEALING AT THAT TIME. THE PATIENT WAS SENT HOME THIS TIME WITH A PICC LINE FOR ANTIBIOTICS AND RECEIVED IV ANTIBIOTICS UNTIL (B)(6) 2024. THE DEVICE WAS NOT RETURNED TO ENOVIS FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. 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 ONE WEEK AFTER WEARING THE POST OP SHOE A SPOT UNDER SECOND TOE RIGHT FOOT. I RETURNED TO DR. EXAMINED THE SHOE AND SAW A PIECE OF METAL UNDER THE CUSHION WAS COMING THROUGH AND RUBBING MY FOOT. THE PATIENT IS DIABETIC, SO THE DR STARTED TREATING THE WOUND, AFTER 3 WEEKS HAD GOTTEN LARGER. THE PATIENT RECEIVED TREATMENT FOR ANOTHER 2 MONTHS TRYING TO GET THE WOUND TO HEAL. ON (B)(6) 2023, THE PATIENT WENT SEPTIC FROM THE WOUND ORAL ANTIBIOTICS WHERE NOT WORKING. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023, WHERE AFTER IV ANTIBIOTICS THEY DECIDED TO AMPUTATE THE PATIENTS TOE. THE PATIENT WENT HOME AND WAS READMITTED INTO THE HOSPITAL ON (B)(6) 2023, TO REMOVE MORE BONE DUE TO NOT HEALING AT THAT TIME. THE PATIENT WAS SENT HOME THIS TIME WITH A PICC LINE FOR ANTIBIOTICS AND RECEIVED IV ANTIBIOTICS UNTIL (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968695 PROCARE SQUARED TOE POST OP SHOE, L KYS DJO LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability