BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM CHG DRESSING

    MDR report key: 2190282 · Received July 25, 2011

    Report

    Report Number
    2110898-2011-00091
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 7, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE NOT RETURNED, NO EVAL CAN BE PERFORMED. DEVICE NOT PROVIDED TO MFR FOR EVAL. COMPLAINT TYPE IS BEING MONITORED AND ANALYZED. (B)(4). 3M'S UPDATES TO THE PACKAGE INSERT, ADD'L INSTRUCTION SHEETS, AND EDUCATIONAL PROGRAMS ARE BEING EFFECTIVE IN ENSURING OPTIMAL USE OF THE PRODUCT. THE INSERT PROVIDES THE FOLLOWING INFO ON 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. INSPECT THE DRESSING DAILY AND CHANGE THE DRESSING AS NECESSARY, IN ACCORDANCE WITH FACILITY PROTOCOL. DRESSING CHANGES SHOULD OCCUR AT LEAST EVERY 7 DAYS, PER CURRENT CDC RECOMMENDATIONS AND MAY BE NEEDED MORE FREQUENTLY WITH HIGHLY EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED. THE TEGADERM (TM) CHG DRESSING SHOULD BE CHANGED AS NECESSARY IF THE DRESSING BECOMES LOOSE, SOILED OR COMPROMISED IN ANY WAY. IF THE SITE IS OBSCURED OR NO LONGER VISIBLE. IF THERE IS VISIBLE DRAINAGE OUTSIDE THE GEL PAD. IF THE DRESSING APPEARS TO BE SATURATED OR OVERLY SWOLLEN.

    Description of Event or Problem · 1

    THIRD DRESSING WAS APPLIED TO PICC CATHETER SITE ON (B)(6). CATHETER SITE DIN HOLE WAS BIGGER THAN LINE AND REDDENED. NO EXUDATE, CLEAN SITE, NO DISCHARGE. ON (B)(6), THE HOLE APPEARED BIGGER AND THERE WAS REDDENING BENEATH THE CHG GEL PAD. SOME OOZING WAS OBSERVED; INFECTION SUSPECTED, ANTIBIOTICS COMMENTED. CHG DRESSING WAS REMOVED AND REPLACED WITH GAUZE AND IV3000. CATHETER WAS REMOVED ON MARCH 23RD AS A RESULT OF THIS INCIDENT. OUTCOME OF THE INCIDENT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGADERM CHG DRESSING UNCLASSIFIED - DRESSING, WOUND, DRUG FRO 3M HEALTH CARE 1657R 2012-06AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other STAT-LOCK