BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 1912804 · Received November 4, 2010

    Report

    Report Number
    1119193-2010-00006
    Event Type
    Other
    Date Received
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. EXTENT OF MEDICAL TREATMENT HAS NOT BEEN ABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED A PRESSURE INJURY ON THEIR CHEEK WHERE THE PLASTIC "MITTEN" SUPPORT OF THE ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER PRESSED THROUGH THE BARRIER TO THE SKIN. THE DEVICE HAD BEEN IN PLACE FOR 5 DAYS. EXTENT OF MEDICAL TREATMENT REQUIRED HAS NOT BEEN PROVIDED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other