BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY ACUTE WITH CATHGRIP

    MDR report key: 14859975 · Received June 29, 2022

    Report

    Report Number
    3001949129-2022-00006
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    April 23, 2022
    Report Date
    June 29, 2022
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    UDI-DI
    00653599000847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS PROVIDED TO REVIEW MANUFACTURING RECORDS. FURTHER INFORMATION WAS REQUESTED BY THE DISTRIBUTOR MULTIPLE TIMES. BIODERM REQUESTED FURTHER INFORMATION ON PRODUCT USE FROM THE CONTACT PROVIDED. NO FURTHER INFORMATION WAS RECEIVED. WILL UPDATE REPORT IF MORE INFORMATION IS ACQUIRED. DISTRIBUTOR ALSO SUBMITTED THIS REPORT AS A MEDWATCH.

    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 DEVELOPED SIGNIFICANT EDEMA, FLUID OVERLOAD, AND PURPLE BLISTER AREAS ON HIS PENIS WHILE USING MEN'S LIBERTY ACUTE. THEY REPORTED THE PATIENT WAS EVALUATED BY THE UROLOGIST, WHO REMOVED THE MLA AND INSERTED A FOLEY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379058 MEN'S LIBERTY ACUTE WITH CATHGRIP EXTERNAL CATHETER NOA BIODERM, INC. BIO2102610 00653599000847

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention