BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEVYN LIFE HEEL (GLOBAL) PACK OF 5

    MDR report key: 6986167 · Received October 29, 2017

    Report

    Report Number
    8043484-2017-00267
    Event Type
    Injury
    Date Received
    October 29, 2017
    Date of Event
    August 26, 2017
    Report Date
    December 8, 2017
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HCP FELT THE ALLEVYN HEEL DRESSING MAY HAVE CAUSED A STAGE 2 PU ON A PATIENT WHEN BEING USED FOR PUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765519 ALLEVYN LIFE HEEL (GLOBAL) PACK OF 5 DRESSING,WOUND,OCCLUSIVE NAD SMITH & NEPHEW MEDICAL LTD. 66801304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other