BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE FOLEY CATHETER

    MDR report key: 20629583 · Received November 5, 2024

    Report

    Report Number
    MW5162247
    Event Type
    Other
    Date Received
    November 5, 2024
    Date of Event
    November 3, 2024
    Report Date
    November 4, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - LAREDO
    Product Code
    PPB
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SILICONE FOLEY CATHETER THE BALLOON WILL NOT INFLATE WITH NORMAL SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944229 SILICONE FOLEY CATHETER FOLEY CATHETER KIT (EXCLUDES HIV TESTING) PPB MEDLINE INDUSTRIES, LP - LAREDO 24CBQ086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown