BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN

    MDR report key: 24184 · Received July 17, 1995

    Report

    Report Number
    24184
    Event Type
    Malfunction
    Date Received
    July 17, 1995
    Date of Event
    May 27, 1995
    Report Date
    June 27, 1995
    Manufacturer
    PUDENZ-SCHULTE MEDICAL, CORP.
    Product Code
    HFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 5/27, DRAIN FRACTURED WHILE PHYSICIAN WAS ATTEMPTING TO REMOVE. ON 5/27, TO OR - UNABLE TO RETRIEVE BROKEN PIECE. ON 5/29, TO OR - SUCCESSFUL REMOVAL OF DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN DRAIN HFL PUDENZ-SCHULTE MEDICAL, CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other