BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 14737514 · Received June 17, 2022

    Report

    Report Number
    3001949129-2022-00004
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 17, 2022
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    UDI-DI
    00653599000168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. HOSPITAL AND/OR DOCTOR'S NOTES CONFIRMING THE UTI OR HOSPITALIZATION WERE REQUESTED AND NEVER RECEIVED. DOCTOR'S NOTES LISTING MEDICAL HISTORY DURING INITIAL PATIENT SET-UP WERE REVIEWED. PATIENT NOTES DATED (B)(6) 2022 LIST THAT THE PATIENT HAS A HISTORY OF URINARY INCONTINENCE, INCOMPLETE BLADDER EMPTYING, AND A PRIOR UTI. REPORT WILL BE UPDATED IF FURTHER NOTES ARE RECEIVED. INCONTINENCE PATIENTS ARE AT A HIGHER RISK FOR INFECTION. PER THE PATIENT'S WIFE, HIS DOCTOR STATED HE COULD CONTINUE USE OF MEN'S LIBERTY. THERE IS NO CONFIRMED HISTORY OF INFECTION RELATED TO OUR PRODUCT. THERE IS NO INDICATION THAT THE DEVICE FAILED TO MEET SPECIFICATIONS OR MALFUNCTIONED, AND THE CAUSE IS NOT ESTABLISHED.

    Description of Event or Problem · 0

    PATIENT'S WIFE CALLED IN ASKING ABOUT BIOPLUS+ WIPES STATING THE PATIENT HAS BLISTERS AT THE HEAD OF HIS PENIS AFTER MEN'S LIBERTY IS REMOVED. PRODUCT SPECIALIST EXPLAINED THEY SHOULD STOP USE UNTIL HE IS HEALED AND EXPLAINED HOW TO PERFORM AN ALLERGY TEST. PATIENT'S WIFE ALSO STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR UTI WHILE USING MEN'S LIBERTY. SHE STATED HE WAS TREATED WITH CEPHALEXIN 500MG AND THAT HIS DOCTOR STATED HE COULD CONTINUE USING MEN'S LIBERTY. PRODUCT SPECIALIST EXPLAINED HE SHOULD WAIT UNTIL CLEARED OF INFECTION BEFORE CONTINUING USE. PATIENT'S WIFE STATED IT WAS THREE YEARS SINCE HIS LAST UTI. PRODUCT SPECIALIST WENT OVER THE APPLICATION INSTRUCTIONS AND PRODUCT USE. PATIENT'S WIFE EXPLAINED SHE USES A PERINEAL CLEANER, SHE USES OTHER CLEANSERS, HE LEAKS DURING APPLICATION, SHE WON'T USE A PENILE CLAMP DURING APPLICATION TO STOP THE LEAKING, HE ONLY USES MEN'S LIBERTY DURING THE DAY, HE IS IN A RECLINER DURING THE DAY, AND HE HAS RETRACTION. PRODUCT SPECIALIST EXPLAINED PROPER POSITIONING TO ALLOW URINE TO FLOW AWAY FROM THE ANATOMY WITH GRAVITY AND HOW TO AVOID SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224413 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 H07302 00653599000168

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization