BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL MEDICAL PRODUCTS

    MDR report key: 2371747 · Received December 13, 2011

    Report

    Report Number
    1929691-2011-00013
    Event Type
    Injury
    Date Received
    December 13, 2011
    Date of Event
    July 28, 2011
    Report Date
    November 23, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY HAS NOT CONTACTED MANUFACTURER TO DESCRIBE INCIDENT OR RETURN PRODUCT. DUE TO THE TIME SINCE THE INCIDENT OCCURRED, NO PAD OR MONITOR HAS BEEN RETURNED FOR EVALUATION. WITHOUT PRODUCT, MANUFACTURER IS UNABLE TO IDENTIFY ANY PRODUCT DEFECT OR MALFUNCTION. MANUFACTURER SENT LETTER EDUCATING FACILITY ON USAGE OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, STANLEY SECURITY SOLUTIONS, INC., RECEIVED A CALL FROM THE (B)(4) SEEKING INFO ABOUT UMP BRAND FALL MONITORS. IT WAS REPORTED THAT A RESIDENT AT (B)(6), FELL AFTER BEING LEFT BY HER SITTER, AND THAT UMP BRAND FALL MONITORS WERE IN USE AT THE TIME. THE RESIDENT SUFFERED A HOLOHEMISPHERIC SUBDURAL HEMATOMA AND A RIGHT HUMOROUS HEMATOMA. TO DATE, USER FACILITY HAS NOT CONTACTED MANUFACTURER TO REPORT A PROBLEM WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL MEDICAL PRODUCTS UMP KMI STANLEY SECURITY SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization