BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGADERM CHG DRESSING

    MDR report key: 2912901 · Received December 18, 2012

    Report

    Report Number
    2110898-2012-00068
    Event Type
    Other
    Date Received
    December 18, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 5, 2012
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED NO EVAL CAN BE PERFORMED. DEVICE NOT PROVIDED TO MANUFACTURER FOR EVAL. COMPLAINT TYPE IS BEING MONITORED AND ANALYZED. TEGADERM CHG COMPLAINTS ARE SIGNIFICANTLY REDUCING BASED ON NUMBER OF UNITS SOLD. 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 CHG DRESSING SHOULD BE CHANGES 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

    CUSTOMER STATES PT WAS RECEIVING ANTIBIOTICS THROUGH PICC LINE IN ARM. THE 1657 TEGADERM CHG COVERED THE INSERTION SITE. DRESSING HAD BEEN IN PLACE FOR MORE THAN 24 HRS AND SEVERAL DRESSING CHANGES HAD BEEN COMPLETED. AFTER 6 WEEKS OF USE, NURSE ALLEGE SKIN BECAME MACERATED UNDER CHG GEL PAD AND APPEARED TO HAVE PUS COMING OUT OF INSERTION SITE. STATED GEL PAD SATURATED AND DRESSING LIFTING. STATES DRESSING CHANGES PERFORMED EVERY 48 HOURS AND THE PICC LINE REMOVED IN RESPONSE TO SKIN CONDITION. SKIN CONDITION WAS IMPROVING AND NO FURTHER TREATMENT. CULTURE WAS PERFORMED WITH NEGATIVE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PICC CVC