BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M TEGADERM CHG DRESSING

    MDR report key: 3911595 · Received June 27, 2014

    Report

    Report Number
    2110898-2014-00049
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 20, 2014
    Manufacturer
    3M HEALTH CARFE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE NOT RETURNED NO EVALUATION CAN BE PERFORMED. COMPLAINT TYPE IS BEING MONITORED AND ANALYZED. TEGADERM CHG COMPLAINTS ARE SIGNIFICANTLY REDUCING BASED ON NUMBER OF UNITS SOLD. THE 3M'S UPDATES TO THE PACKAGE INSERT, ADDITIONAL INSTRUCTION SHEETS, AND EDUCATIONAL PROGRAMS ARE BEING EFFECTIVE IN ENSURING OPTIMAL USE OF THE PRODUCT.

    Description of Event or Problem · 1

    LITERATURE REPORTED (B)(6) YEAR OLD MALE ICU PATIENT WITH LEFT GROIN, LEFT NECK AND RIGHT WRIST CENTRAL VENOUS CATHETER SITES. REPORTED TEGADERM CHG DRESSING COVERED CATHETER SITES. LITERATURE REPORTED CATHETER SITE EROSIVE LESIONS AT LEFT GROIN, LEFT NECK AND RIGHT WRIST AT 8 DAYS POST INSERTION. CULTURES NEGATIVE, WOUND CARE TREATMENT REPORTED AS LEFT FEMORAL CAC REMOVAL, TOPICAL ANTIBIOTICS, NONADHERENT DRESSINGS AND PAPER TAPE. LESIONS RESOLVED IN NON SPECIFIED AMOUNT OF DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376344 3M TEGADERM CHG DRESSING UNCLASSIFIED - DRESSING, WOUND, DRUG FRO 3M HEALTH CARFE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention