BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON BRANDS

    MDR report key: 25015228 · Received April 28, 2026

    Report

    Report Number
    1451040-2026-00019
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    April 11, 2026
    Report Date
    April 28, 2026
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Product Code
    GBM
    UDI-DI
    10612479245850
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER BECAME CLOGGED IN THE PATIENT. PATIENT WAS SENT TO THE ER WHERE BLOOD PRESSURE WAS REPORTED TO BE OVER 300 MM HG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072935 MCKESSON BRANDS CATHETER, FOLEY STRT TIP SIL COATED LTX 16FR 5CC GBM WELL LEAD MEDICAL CO. LTD CAOE06-01 10612479245850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention