BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN CURITY

    MDR report key: 6098770 · Received November 9, 2016

    Report

    Report Number
    MW5065966
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    September 16, 2016
    Report Date
    November 2, 2016
    Manufacturer
    COVIDIEN LLC
    Product Code
    GER
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COTTON BALL USED IN COVIDIEN IODOFORM PACKING STRIPS PACKAGING WAS UNKNOWINGLY PLACED IN PT WITH THE PACKING STRIP. WHEN PACKING STRIP WAS REMOVED FROM PT FOR WOUND VAC PLACEMENT, COTTON BALL WAS NOT VISUALIZED-BELIEVED TO HAVE TRAVELLED DEEPER, BUT WAS FOUND WHEN INFECTION WAS CLEANED AND COTTON BALL WAS REMOVED AFTER WOUND VAC USED TO ASSIST WOUND HEALING. COTTON BALL NOT SENT TO LAB, WAS REMOVED IN PHYSICIAN OFFICE. DOSE OR AMOUNT: SMALL COTTON BALL, FREQUENCY: 1, ROUTE: PACKED WITH PACKING STRIP. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. DIAGNOSIS OR REASON FOR USE: PACEMAKER ADJUSTMENTS. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742385 COVIDIEN CURITY IODOFORM PACKING STRIP GER COVIDIEN LLC 16H084862

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization