BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM DRESSING

    MDR report key: 4223672 · Received October 31, 2014

    Report

    Report Number
    1049092-2014-00574
    Event Type
    Injury
    Date Received
    October 31, 2014
    Report Date
    October 22, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED AN ADHESIVE FOAM DRESSING WAS APPLIED TO AN UNSPECIFIED WOUND ON THE PATIENT'S LOWER LEFT TIBIA. THE DRESSING WAS REPORTEDLY CHANGED TWICE PER WEEK. SOMETIME AFTER APPLICATION, THE PATIENT DEVELOPED "SERIOUS REDNESS (AND PEELING SKIN". THE PATIENT HAS DISCONTINUED USE OF THE DRESSING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698117 AQUACEL FOAM DRESSING AQUACEL FOAM ADHESIVE AND NON AHES FRO CONVATEC INC. 420680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other