BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEVYN LIFE M 12.9X12.9 CTN10

    MDR report key: 5913828 · Received August 30, 2016

    Report

    Report Number
    8043484-2016-00111
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Date of Event
    August 12, 2016
    Report Date
    July 23, 2025
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    NAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW MEDICAL LTD IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW MEDICAL LTD HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & SMITH & NEPHEW MEDICAL LTD, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW MEDICAL LTD OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED ALLEVYN LIFE WOULD NOT ABSORB THICK DRAINAGE, LEADING TO MACERATION. HYPERGRANULATION OCCURED REQUIRING TREATMENT WITH AGN03. ADDITIONALLY PERIWOUND WAS PROTECTED WITH SKIN PROTECTANT AND TREATMENT WAS SWITCHED TO A MORE BREATHABLE DRESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED ALLEVYN LIFE WOULD NOT ABSORB THICK DRAINAGE, LEADING TO MACERATION. HYPER GRANULATION OCCURRED REQUIRING TREATMENT WITH AGN03. ADDITIONALLY, PERI WOUND WAS PROTECTED WITH SKIN PROTECTANT AND TREATMENT WAS SWITCHED TO A MORE BREATHABLE DRESSING.

    Description of Event or Problem · 1

    IT WAS REPORTED ALLEVYN LIFE WOULD NOT ABSORB THICK DRAINAGE, LEADING TO MACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568297 ALLEVYN LIFE M 12.9X12.9 CTN10 DRESSING, WOUND, OCCLUSIVE NAD SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other