BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM SHORT SECONDARY PORT

    MDR report key: 2172319 · Received May 9, 2011

    Report

    Report Number
    2647580-2011-00315
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    April 12, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: THE SEAL INSIDE THE PEDIPORT BROKE INTO FRAGMENTS WHICH MAY REMAIN INSIDE THE PTS CAVITY. NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE WERE REPORTED. NO PT INJURY WAS REPORTED. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GDW USSC PUERTO RICO P1A0499

    Patients

    Seq Age Sex Outcome Treatment
    1