BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR FAST

    MDR report key: 1904412 · Received November 16, 2010

    Report

    Report Number
    1904412
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 16, 2010
    Manufacturer
    HOLLISTER INC
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED A STAGE 4 PRESSURE ULCER UNDER DUODERM PAD THAT COVERS A PORTION OF THE CHEEK. FIRST EVIDENCE OF DEEP TISSUE INJURY WAS NOTED ON DAY 12. DEVICE HAD BEEN ON PATIENT FOR 12 DAYS.======================HEALTH PROFESSIONAL'S IMPRESSION======================PATIENT CRITICALLY ILL WITH MULTIPLE RISK FACTORS FOR SKIN BREAKDOWN. THREE ASPECTS RELATED TO DESIGN OF ANCHOR FAST DEVICE MAY HAVE CONTRIBUTED TO PRESSURE ULCER: 1. DESIGNED TO STAY IN PLACE FOR PROLONGED PERIOD OF TIME (REP FROM COMPANY GAVE AN EXAMPLE OF 5-7 DAYS). 2. DUODERM PADS THAT COVER THE CHEEKS ARE OPAQUE SO NURSE IS NOT ABLE TO ASSESS CONDITION OF SKIN UNDERNEATH. 3. THE DUODERM PAD IS ATTACHED TO A HARD PLASTIC PORTION OF THE DEVICE THAT CONNECTS THE FRONT OF THE DEVICE TO THE STRAP THAT GOES BEHIND THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER CBH HOLLISTER INC * N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R OTHER