BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEVYN LIFE S 10.3X10.3 CTN10

    MDR report key: 5152744 · Received October 15, 2015

    Report

    Report Number
    8043484-2015-00279
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    July 15, 2015
    Report Date
    September 25, 2015
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCTS DOES NOT ABSORB WELL AND REQUIRES CHANGING WITHIN THE 7 DAY WEAR TIME. IT WAS ALSO NOTICED THAT THE WOUNDS ARE MACERATED AND TAKING LONGER THAN THEY USUALLY TAKE TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684397 ALLEVYN LIFE S 10.3X10.3 CTN10 DRESSING, WOUND, OCCLUSIVE NAD SMITH & NEPHEW MEDICAL LTD. 66801067

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR