BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM CHG DRESSING

    MDR report key: 2142337 · Received June 20, 2011

    Report

    Report Number
    2110898-2011-00076
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    April 4, 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: NO EVALUATION WILL BE PERFORMED. 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 HIGHLY EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED.

    Description of Event or Problem · 1

    PATIENT SUFFERED SKIN REACTION UNDER THE GEL PAD OF THE DRESSING AROUND THE PICC EXIT SITE. THE EXIT SITE WAS RED AND THERE WAS AN AREA OF EXUDATE AROUND THE EXIT SITE. SKIN WAS PREPPED WITH CLORAPREP AND ALCOHOL SANI-CLOTH CHG 2%. PATIENT TAKES CHEMOTHERAPY DRUGS (CISP 15 FR). THE DRESSING WAS IN PLACE FOR MORE THAN 24 HOURS BEFORE THE SYMPTOM DEVELOPED ((B)(6) OF THE DRESSING). THE SYMPTOMS DID NOT OCCUR WITH THE FIRST USE OF THE DRESSING. A TOTAL OF THREE DRESSINGS HAD BEEN USED AND APPLIED ON THIS PATIENT. THE CATHETER WAS REMOVED AS A RESULT OF THIS INCIDENT. DUE TO THE SYMPTOMS, THE USE OF THE TEGADERM CHG DRESSING WAS DISCONTINUED. THE HOLE WAS PACKED WITH A SILVER AQUACELL (WOUND SWAB) AND DRESSED. THE PATIENT WAS GIVEN AN ORAL ANTIBIOTIC. THE OUTCOME OF THE INCIDENT WAS REPORTED AS UNKNOWN FOR THE SKIN REACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other STAT-LOCK