BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL PATTIE, 1/2 X 1/2

    MDR report key: 3793704 · Received May 6, 2014

    Report

    Report Number
    1226348-2014-11568
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    July 31, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LWH
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE MISCOUNTED PATTIE CARDS WERE TESTED ON (B)(4) TO EVALUATE MACHINE PERFORMANCE. MACHINE REJECTED EVERY MISCOUNTED PATTIE CARD. THE MANUFACTURING DOCUMENTATION FOR LOT 330966 WAS PULLED AND REVIEWED. (B)(4). ROOT CAUSE IS LIKELY DUE TO OPERATOR ERROR. MACHINE (B)(4) WAS REVIEWED AND TESTED MULTIPLE TIMES WITH MISCOUNTED PATTIE CARDS AND THEY WERE REJECTED EVERY TIME. PER THE REQUIREMENTS OF THE SPECIFICATION, (B)(4). TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED "PACKAGE NORMALLY CONTAINS 10 PATTIES, BUT UPON OPENING, THEY SAW THAT IT HAD ONLY 9 IN THE BOX. THEY PROCEEDED BY OPENING A NEW SAME LIKE PRODUCT. NO DELAY AND NO AE TO PATIENT". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272085 SURGICAL PATTIE, 1/2 X 1/2 SURGICAL SPONGE LWH CODMAN & SHURTLEFF, INC. 330966

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention