BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM CHG DRESSING

    MDR report key: 1843454 · Received September 20, 2010

    Report

    Report Number
    2110898-2010-00104
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 22, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. DRESSINGS CHANGES MAY BE NEEDED MORE FREQUENTLY WITH HIGH EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED.

    Description of Event or Problem · 1

    HEALTH CARE FACILITY REPORTED THAT A PT HAD DEVELOPED REDNESS AND SKIN BLISTERING UNDER THE CHG GEL PAD AND THEN SPREAD BEYOND THE CHG GEL PAD, INVOLVING THE SKIN AREA UNDER THE ENTIRE DRESSING. CHEMOTHERAPY DRUGS WERE BEING ADMINISTERED VIA THE VASCULAR ACCESS DEVICE. THE CATHETER WAS REMOVED DUE TO THE SKIN REACTION. THE PT'S STATUS OF THE SKIN REACTION WAS REPORTED AS IMPROVING. OTHER NOTES: THE DRESSING WAS IN PLACE FOR NINE DAYS BECAUSE, THE PT WAS OUT OF TOWN. PT NOTICED, THE INCREASING SKIN IRRITATION AND REMOVED THE DRESSING ON HIS OWN AT HOME, AND THEN APPLIED A DRY STERILE DRESSING. NURSE OBSERVED THE SKIN AFTER DRY DRESSING HAD BEEN IN PLACE FOR THREE DAYS. THE SKIN REMAINED REDDENED AND THERE WERE WATERY BLISTERS UNDER THE ENTIRE AREA UNDER THE DRESSING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention CATHETER SECURED BY RETENTION SUTURES