BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY ACUTE

    MDR report key: 18248379 · Received December 1, 2023

    Report

    Report Number
    3001949129-2023-00002
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 2, 2023
    Report Date
    December 1, 2023
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PART NUMBER WAS RECEIVED TO VERIFY THAT IT WAS IN FACT A BIODERM PRODUCT. NO LOT NUMBER WAS PROVIDED TO REVIEW MANUFACTURING RECORDS. UNABLE TO INVESTIGATE FURTHER. FURTHER INFORMATION ON PRODUCT USE WAS REQUESTED MULTIPLE TIMES, BUT NONE HAS BEEN RECEIVED. WILL UPDATE THE REPORT IF MORE INFORMATION IS ACQUIRED.

    Description of Event or Problem · 0

    DISTRIBUTOR INFORMED BIODERM OF A COMPLAINT THEY RECEIVED BY ONE OF THEIR CUSTOMERS (HOSPITAL). THE HOSPITAL REPORTED AN UNCIRCUMCISED MALE PATIENT WHO DEVELOPED THE APPEARANCE OF PURPLISH/REDDISH DISCOLORATION, SWELLING, AND AN OPEN LESION ON THE AREA BEHIND THE GLAND OF THE ANATOMY WHILE USING MEN'S LIBERTY ACUTE. THEY REPORTED THE PATIENT WAS EVALUATED BY THE INPATIENT WOC CONSULT, WHO DISCONTINUED THE MLA, AND AN ALTERNATIVE DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451303 MEN'S LIBERTY ACUTE EXTERNAL CATHETER NOA BIODERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention