BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM TRANSPARENT FILM DRESSING

    MDR report key: 4017584 · Received July 25, 2014

    Report

    Report Number
    2110898-2014-00040
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 4, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NOTE: VECTIBIX WAS REPORTED AS ONE OF THE CHEMOTHERAPY MEDICATIONS USED FOR TREATMENT. PACKAGE INSERT LISTS WARNING FOR DERMATOLOGIC TOXICITY. THERE WAS ALSO LEAKING NOTED IN THE REPORT. IT IS NOT KNOWN IF THE SKIN REACTION WAS DUE TO DRESSING OR MEDICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT WITH A CENTRAL VENOUS ACCESS PORT WAS RECEIVING VECTIBIX, IRINOTEKAN AND FLUORACIL FOR CHEMOTHERAPY TREATMENT. TEGADERM 1626W WAS USED FOR IV DRESSING AND CUSTOMER REPORTED A SEVERE SKIN REACTION UNDER THE ENTIRE FILM DRESSING. CUSTOMER REPORTED MEDICAL TREATMENT REQUIRED AND REPORTED PRONTOSAN SOLUTION/MEPILEX, AQVITOX SOLUTION / MELGISORB AG ABSORBING DRESSING / NON WOVEN (VLIVAZEL), AQVITOXEM AND EPADERM CREAM WERE ALL USED FOR TREATMENT. REPORTED REACTION WAS IMPROVED AFTER 5 DAYS AND TOOK 14 DAYS TO RESOLVE. REPORTED LEAKAGE WAS NOTED AT THE SITE AND PRODUCT WAS DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436754 TEGADERM TRANSPARENT FILM DRESSING 878.4020 DRESSING, WOUND, OCCLUSIVE NAD 3M HEALTH CARE NA 2016-07-TT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention VECTIBIX| FLUORACIL| IRINOTEKAN