BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SILICONE FOLEY CATHETER

    MDR report key: 14522163 · Received May 26, 2022

    Report

    Report Number
    MW5109960
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 24, 2022
    Report Date
    May 25, 2022
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLEY CATHETER SNAPPED IN HALF WHEN PATIENT ATTEMPTED TO REMOVE. DISTAL PORTION OF CATHETER REMAINED IN BLADDER AND REQUIRED RIGID CYSTOSCOPY FOR REMOVAL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197342 SELECT SILICONE FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL MEDLINE INDUSTRIES, LP - NORTHFIELD MAYBE 21HBD121

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention