BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENROSE DRAIN

    MDR report key: 12638810 · Received October 14, 2021

    Report

    Report Number
    MW5104645
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 12, 2021
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PLACING THE PENROSE DRAIN DURING A CAROTID ENDARTERECTOMY, THE DRAIN BROKE INTO 3 PIECES. NO ADDITIONAL TESTS WERE REQUIRED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528034 PENROSE DRAIN SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE EYZ MEDLINE INDUSTRIES, LP - NORTHFIELD DYND50420 6052003002

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization