BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-CATH¿

    MDR report key: 17070462 · Received June 6, 2023

    Report

    Report Number
    17070462
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    April 14, 2023
    Report Date
    May 24, 2023
    Manufacturer
    MEDIPLUS LTD
    Product Code
    QGC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FOLEY CATHETER FOUND TO BE COMPLETELY DISLODGED WITH BALLOON DEFLATED. WHEN BALLOON WAS TESTED, THERE WAS AN OBVIOUS LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697043 S-CATH¿ CATHETER, SUPRAPUBIC (AND ACCESSORIES) QGC MEDIPLUS LTD 5756

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA Unknown