BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEXIS WOUND RETRACTOR SMALL FOR 2.5-6CM INCISIONS

    MDR report key: 3113214 · Received May 8, 2013

    Report

    Report Number
    2027111-2013-00157
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 2, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    KKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT# IS PROVIDED. A DEVICE HISTORY REPORT IS CURRENTLY BEING REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LOBECTOMY: "WOUND RETRACTOR POPPED OUT DURING SURGERY. INCISION WAS 5CM LONG AND WAS CHECKED FOR UNDERLYING OBSTRUCTIONS. SOME BLOOD FLEW IN THE AIR AS THE DEVICE WAS RELEASE AND GOT ON THE ASSISTING NURSE. ADDITIONAL FEEDBACK FROM OTHER SURGEONS AT THE HOSPITAL INDICATE THAT RECENT DESIGN CHANGES TO THE PRODUCT HAVE MADE IT MORE DIFFICULT TO USE IN THIS TYPE OF SURGERY." PATIENT STATUS: NO IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202189 ALEXIS WOUND RETRACTOR SMALL FOR 2.5-6CM INCISIONS ALEXIS KKX APPLIED MEDICAL C8301 1189804

    Patients

    Seq Age Sex Outcome Treatment
    1 NUMBER 11 BLADE TO PREPARE THE INCISION