BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENS LIBERTY ACUTE WITH CATHGRIP

    MDR report key: 14550613 · Received May 31, 2022

    Report

    Report Number
    1417592-2022-00070
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    April 23, 2022
    Report Date
    May 31, 2022
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    UDI-DI
    00653599000847
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN UNCIRCUMCISED MALE PATIENT HAD AN EXTERNAL URINARY DRAINAGE SYSTEM APPLIED TO THE GLANS OF HIS PENIS WHEN THE PENIS AND FORESKIN DEVELOPED SIGNIFICANT EDEMA AND FLUID OVERLOAD. THE FACILITY REPORTED THAT THE PENIS APPEARED WITH PURPLE BLISTER AREAS. THE UROLOGIST EVALUATED THE PATIENT, REMOVED THE EXTERNAL URINARY DRAINAGE SYSTEM AND INSERTED A #16 SILICONE FOLEY CATHETER. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNCIRCUMCISED MALE PATIENT HAD AN EXTERNAL URINARY DRAINAGE SYSTEM APPLIED TO HIS PENIS WHEN HE EXPERIENCED AN ADVERSE EVENT AND REQUIRED A FOLEY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678736 MENS LIBERTY ACUTE WITH CATHGRIP MENS LIBERTY ACUTE WITH CATHGRIP NOA BIODERM, INC. BIO2102610 00653599000847

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention