BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEVYN GENTLE BORDER

    MDR report key: 5553744 · Received April 7, 2016

    Report

    Report Number
    8043484-2016-00038
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    March 10, 2016
    Report Date
    March 10, 2016
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MAN HAD ALLEVYN FOR THE STOMA AT THE SUPRAPUBIC-KAD. THE DRESSING DIDN'T ABSORB ALL THE EXUDATE AND A THICK MASS WAS CREATED BETWEEN BANDAGES AND STOMA. IT WAS BAD SMELL AND THE SKIN WAS IRRITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215350 ALLEVYN GENTLE BORDER DRESSING, WOUND, OCCLUSIVE NAD SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other