BEUDAMED
    FDA Adverse Event Summary report: N

    5348, PATIENT CARE KIT

    MDR report key: 2573223 · Received March 26, 2012

    Report

    Report Number
    2921578-2012-00002
    Date Received
    March 26, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 19, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    CCX
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WILL PROVIDE ADDITIONAL ANALYSIS UPON COMPLETION OF INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    FEMALE PT HAD REACTION TO STRAP HOLDING CHIN. THE REACTION CAUSED BLISTERS ON THE CHIN. THE HOSPITAL STATED THEY OVERTIGHTENED STRAP ON PT BECAUSE HER POSITION DURING SURGERY WAS NOT STABLE. IN ADDITION, THE PT WAS STATED AS OBESE. DURING THE SURGERY, THE PT SHIFTED LATERALLY, AND THE HOSPITAL BELIEVES THIS AND THE OVER-TIGHTENING CAUSED THE BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5348, PATIENT CARE KIT SUPPORT, PATIENT POSITION (CCX) CCX MIZUHO OSI 5348 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other