BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM

    MDR report key: 11991473 · Received June 11, 2021

    Report

    Report Number
    MW5101853
    Event Type
    Injury
    Date Received
    June 11, 2021
    Report Date
    June 8, 2021
    Manufacturer
    3M COMPANY
    Product Code
    KMK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SOLICITED CALL TO THE PATIENT'S MOTHER. PT'S MOTHER REPORTED SOME REDNESS AND IRRITATION AROUND THE PT'S PORT SITE AFTER TEGADERM DRESSING WAS REMOVED. PT'S MOTHER REQUESTING A DIFFERENT DRESSING. CONSENT TO CONTACT THE PATIENT'S HCP WAS NOT ASKED. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877523 TEGADERM DEVICE, INTRAVASCULAR CATHETER SECUREMENT KMK 3M COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1