BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3575900 · Received November 19, 2013

    Report

    Report Number
    3575900
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 14, 2013
    Manufacturer
    CAREFUSION 213 LLC
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    A MALE PATIENT PRESENTED TO EMERGENCY WITH RIGHT LOWER QUADRANT ABDOMINAL PAIN - TO SURGERY FOR LAPAROSCOPIC APPENDECTOMY. WHILE BEING PREPARED FOR SURGERY AND THE SITE BEING CLIPPED; THE PATIENT'S SKIN WAS NICKED ON THE SIDE OF ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599765 * CLIPPER LWK CAREFUSION 213 LLC * *
    599766 * CLIPPER LWK CAREFUSION 213 LLC * *
    599767 * CLIPPER LWK CAREFUSION 213 LLC * *
    599792 * CLIPPER LWK CAREFUSION 213 LLC * 0413
    599793 * CLIPPER LWK CAREFUSION 213 LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR PATIENT BEING PREPARED FOR SURGERY.
    2 82 YR
    3 49 YR
    4 66 YR
    5 33 YR