BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM CHG DRESSING

    MDR report key: 1873593 · Received October 12, 2010

    Report

    Report Number
    2110898-2010-00112
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OR LOT CODE NOT PROVIDED TO MANUFACTURER FOR EVALUATION. COMPLAINT TYPE WILL BE MONITORED. THE INSERT PROVIDES THE FOLLOWING INFORMATION REGARDING OBSERVATION AND WHEN A DRESSING SHOULD BE CHANGED. SITE CARE: THE SITE SHOULD BE OBSERVED DAILY FOR SIGNS OF INFECTION OR OTHER COMPLICATIONS. IF INFECTION IS SUSPECTED, REMOVE THE DRESSING, INSPECT THE SITE DIRECTLY, AND DETERMINE APPROPRIATE MEDICAL INTERVENTION. INFECTION MAY BE SIGNALED BY FEVER, PAIN, REDNESS, SWELLING, OR UNUSUAL ODOR OR DISCHARGE. CHANGE THE DRESSING AS NECESSARY, IN ACCORDANCE WITH FACILITY PROTOCOL; DRESSING CHANGES SHOULD OCCUR AT LEAST EVERY 7 DAYS, PER CURRENT CDC RECOMMENDATIONS. DRESSING CHANGES MAY BE NEEDED MORE FREQUENTLY WITH HIGHLY EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED.

    Description of Event or Problem · 1

    HEALTH CARE FACILITY REPORTED THAT TWO PTS HAD A CRBSI AND/OR A SKIN REACTION. HOWEVER, THE HEALTH CARE FACILITY IS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION PERTAINING TO THE MANUFACTURER'S REQUEST TO COMPLETE A QUESTIONNAIRE ON EACH OF THE TWO PTS. DUE TO INSUFFICIENT INFORMATION RECEIVED, THIS COMPLAINT IS BEING CLOSED INTERNALLY AND WILL BE RE-OPENED UPON ANY ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGADERM CHG DRESSING ANTIMICROBIAL IV SECUREMENT DRESSING FRO 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention