BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON BRANDS

    MDR report key: 22886554 · Received August 25, 2025

    Report

    Report Number
    1451040-2025-00069
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 25, 2025
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Product Code
    GBM
    UDI-DI
    10612479245829
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL CODE E - 4581. SPLITTING OF THE PENIS FOLLOWING USE OF URETHRAL CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT FOLLOWING USE OF THESE CATHETERS, SHORT TERM MALE PATIENTS EXPERIENCED SPLITTING OF THE PENIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553093 MCKESSON BRANDS CATHETER, FOLEY STRT TIP SIL COATED LTX 14FR 5CC GBM WELL LEAD MEDICAL CO. LTD CAOE02-03 10612479245829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other