BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEVYN CAVITY 12 X 4CM TUBULAR CTN 5

    MDR report key: 5020997 · Received August 21, 2015

    Report

    Report Number
    8043484-2015-00250
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 31, 2015
    Report Date
    July 31, 2015
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENTS WOUND WAS DRESSED IN CLINIC, WITH 2 ALLEVYN CAVITY DRESSINGS. FOLLOWING THE DRESSING CHANGE 2 DAYS LATER AT HOME (AS INSTRUCTED) THE WOUND WAS OBSERVED TO BE ODOROUS AND PUS FILLED. PAIN, FEVER AND CHILLS WERE ALSO EXPERIENCED WHILST THE PRODUCT WAS IN THE WOUND CAVITY, IT WAS ALSO NOTED BY THE PATIENT THAT THE DRESSING USED HAD PASSED THEIR EXPIRY DATE OF 2014-06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553520 ALLEVYN CAVITY 12 X 4CM TUBULAR CTN 5 DRESSING NAD SMITH & NEPHEW MEDICAL LTD. 66007329 1126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S