BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 18459140 · Received January 5, 2024

    Report

    Report Number
    3001949129-2023-00004
    Event Type
    Injury
    Date Received
    January 5, 2024
    Report Date
    January 5, 2024
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT ORDERS THROUGH A MEN'S LIBERTY DISTRIBUTOR. NO LOT NUMBER OR FURTHER INFORMATION WAS RECEIVED TO LOOK AT MANUFACTURING RECORDS. IT IS UNCLEAR AS TO HOW HE WAS USING MEN'S LIBERTY OR WHOAT COULD HAVE CAUSED UTI SYMPTOMS. SALES MANAGER EMAILED HIM ON (B)(6) 2023 STATING THAT THE PRODUCT SPECIALISTS ARE THE BEST FOR HANDLING THE CONCERNS, BUT AT HIS REQUEST, THEY WILL NOT BE CONTACTING HIM. QUALITY ASKED THE SALES MANAGER IF THE NAME OF THE HOSPITAL COULD BE ACQUIRED TO REQUEST VISIT NOTES ON HIS HOSPITALIZATION AND TO LET HIM KNOW HIS REPORT WOULD BE REPORTED TO THE FDA. SALES MANAGER EMAILED HIM TO ASK, BUT HE DID NOT REPLY. HOSPITAL NOTES WERE NOT ABLE TO BE REQUESTED, AND THUS NOT OBTAINED TO CONFIRM HIS REPORT. IT COULD NOT BE CONFIRMED HOW HE WAS USING THE PRODUCT, SO THE CAUSE CANNOT BE ESTABLISHED. INCONTINENCE PATIENTS ARE AT A HIGHER RISK FOR INFECTION. 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 WILL BE REPORTED. REPORTING THE COMPLAINT WAS DELAYED DUE TO UNSUCCESSFUL ATTEMPTS TO RETRIEVE MORE INFORMATION. REPORT WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    PATIENT EMAILED BIODERM, INC.'S SALES MANAGER ON (B)(6) 2023 TO REPORT AN UTI. PATIENT IS A NEW USER WHO IS ALSO A PARAPLEGIC. PATIENT STATED HE HAS BEEN USING THE PRODUCT SINCE OCTOBER AND THE PROBLEM WAS WITH THE LEG BAG NOT HAVING AN ANTI-REFLUX VALVE, ALLOWING THE URINE TO STAY NEAR THE ANATOMY. THE SALES MANAGER SENT THE EMAIL TO THE PRODUCT SPECIALISTS FOR FOLLOW-UP. PRODUCT SPECIALIST ATTEMPTED TO CONTACT THE PATIENT TO TROUBLESHOOT THE PROBLEM BY PHONE AND BY EMAIL. PATIENT EMAILED THE SALES MANAGER AGAIN ON (B)(6) 2023 ASKING NOT TO BE CONTACTED BY OUR CALL CENTER. PATIENT STATED HE WAS HOSPITALIZED DUE TO THE UTI AND HAS SPOKEN WITH AN ATTORNEY. PATIENT DID NOT PROVIDE THE MEN'S LIBERTY LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986190 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization