BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1/2 X 1/2

    MDR report key: 3790023 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11511
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE SAMPLE WAS RETURNED AND THE PRODUCTION DOCUMENTATION WAS PULLED AND REVIEWED FOR PRODUCT CODE 801400, LOT # 211731. THE PRODUCT WAS PRODUCED IN MARCH OF 2012. THIS LOT WAS PENDING A (B)(4) (REPLACEMENT OF ULTRASONIC WELDING HORN) WHICH IS UNRELATED TO THIS CUSTOMER COMPLAINT. THE PRODUCT IS MANUALLY PLACED IN A SEALER. (B)(4). THE COMPLAINT WAS REVIEWED WITH THE RESPONSIBLE OPERATORS TO RAISE AWARENESS OF THE ISSUE. BASED ON THE INVESTIGATION THIS COMPLAINT IS CONSIDERED CLOSED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR EVENTS.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND INFORMED THAT: "HAD A PACKAGE OF PATTIES WITH HAIR INSIDE. THIS WAS NOTICED BEFORE USE WITHOUT ANY DELAY IN SURGERY. PLEASE SEND A WARRANTY REPLACEMENT". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269349 SURG PAT XRAY 1/2 X 1/2 PADDIE, COTTONOID HBA CODMAN & SHURTLEFF 211731

    Patients

    Seq Age Sex Outcome Treatment
    1