BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM BODY

    MDR report key: 20101353 · Received August 29, 2024

    Report

    Report Number
    3005778470-2024-00915
    Event Type
    Injury
    Date Received
    August 29, 2024
    Report Date
    August 5, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FON
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 3005778470.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE END USER THAT SHE DEVELOPED A RED SKIN CONDITION IN A MIRROR IMAGE OF THE APPLIANCE MASS. WHEN SHE REMOVED IT, SHE STATED THAT HER SKIN WAS BRIGHT RED, INFLAMED AND PAINFUL UNDER THE MASS. ADDITIONALLY, REPORTED THAT SHE HAD AN INFECTION. SHE WENT TO THE HOSPITAL, AND SHE WAS ADMITTED FOR FOUR DAYS. SHE REPORTED THAT SHE WAS ON UNKNOWN INTRAVENOUS (IV) ANTIBIOTICS, ANTI-FUNGAL AND FLUIDS FOR HYDRATION. HOWEVER, SHE WAS UNABLE TO SPECIFY HER CLEANING ROUTINE BUT STATED THAT NO STING BARRIER AND STOMA POWDER WAS USED PRIOR TO PRODUCT APPLICATION. THE END USER HAD RETURNED TO USE OF ANOTHER COMPANY'S APPLIANCE AND THE SKIN ISSUES HAD BEEN RESOLVED. NO PHOTO WAS AVAILABLE AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597347 ESTEEM BODY BAG, DRAINAGE, WITH ADHESIVE, OSTOMY FON UNOMEDICAL S.R.O. 423651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female