BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 20745360 · Received November 21, 2024

    Report

    Report Number
    3001949129-2024-00002
    Event Type
    Injury
    Date Received
    November 21, 2024
    Report Date
    September 27, 2024
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    UDI-DI
    00653599000168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED, AND THERE WERE NO DISCREPANCIES NOTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. PRODUCT RETAIN DRAINED PROPERLY WHEN TESTED WITH WATER. DOCTOR'S NOTES WERE NOT RECEIVED BUT A REVIEW OF THE PATIENT HISTORY NOTES PROVIDED DURING INITIAL ACCOUNT SETUP WAS CONDUCTED. PATIENT HISTORY NOTES SHOWED REOCCURRING HISTORY OF URINARY INCONTINENCE, ACUTE CYSTITIS WITH HEMATURIA, AND A PREVIOUS UTI. THE PATIENT'S MEDICAL HISTORY OF INCONTINENCE COULD CONTRIBUTE TO AN INFECTION, AS INCONTINENCE PATIENTS ARE AT A HIGHER RISK FOR INFECTION, BUT THE CAUSE OF THIS REPORT IS UNCLEAR. PRODUCT SPECIALIST FOLLOWED UP WITH PATIENT'S WIFE ON 09/17/24, AND SHE STATED EVERYTHING IS GOING GOOD. THERE IS NO INDICATION THAT THE DEVICE FAILED TO MEET SPECIFICATIONS OR MALFUNCTIONED. THERE IS NO CONFIRMED HISTORY OF INFECTION RELATED TO OUR PRODUCT. AS A SHOW OF AN ABUNDANCE OF CAUTION, THE COMPLAINT IS BEING REPORTED. COMPLAINT WILL BE UPDATED IF MORE INFORMATION IS PROVIDED BY THE PATIENT OR DOCTOR'S NOTES CONFIRMING INFECTION ARE RECEIVED.

    Description of Event or Problem · 0

    PATIENT'S WIFE CALLED IN REPORTING THE PATIENT WAS IN THE HOSPITAL WITH A UTI AFTER USING MEN'S LIBERTY. SHE STATED HE WAS PUT ON 5 DAYS OF ANTIBIOTICS. SHE MENTIONED THAT A SMALL PORTION OF URINE IN THE ML TUBE DOESN'T DRAIN DOWN INTO THE COLLECTION POUCH. PRODUCT SPECIALIST WENT OVER APPLICATION AND TROUBLESHOOTED WAYS TO ENSURE PROPER DRAINIAGE OF URINE. PATIENT'S WIFE STATED THAT SHE APPLIES THE FACEPLATE SEAL TIGHTLY, AND THE PRODUCT SPECIALIST INFORMED HER TO APPLY CORRECTLY WITHOUT IT BEING TOO TIGHT TO PREVENT INJURY. PATIENT'S WIFE STATED THEY WOULD REFRAIN FROM USING ML FOR ANOTHER WEEK UNTIL HE IS CLEARED OF THE UTI. SHE ALSO MENTIONED HE HAS HAD UTIS IN THE PAST BUT NOTHING CHRONIC. PATIENT'S WIFE PROVIDED ML LOT # K17601. PRODUCT SPECIALIST REACHED OUT TO THE DOCTOR ON FILE TO REQUEST DOCTOR'S NOTES ON PATIENT MEDICAL HISTORY AND CONFIRMATION OF INFECTION BUT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427367 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 K17601 00653599000168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization