BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABS

    MDR report key: 1080424 · Received July 21, 2008

    Report

    Report Number
    1929691-2008-00003
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    February 11, 2008
    Report Date
    July 16, 2008
    Manufacturer
    STANLEY-SENIOR TECHNOLOGIES
    Product Code
    KMI
    PMA / PMN Number
    K924433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR CONTACTED END USER, AFTER RECEIVING LETTER OF INCIDENT. THEY DISCARDED SUSPECTED PRODUCT. THEREFORE AN EVAL CAN NOT BE PERFORMED.

    Description of Event or Problem · 1

    LETTER DATED 7/2/2008 TO MFR FROM PROCLAIM AMERICA INC. : PT WAS ADMITTED IN 2008 AND FELL ON FIVE DAYS LATER, RESULTING IN A FRACTURED LEFT FEMUR. "OUR INVESTIGATION TO DATE INDICATES THAT THE BED ALARM ACTUALLY MALFUNCTIONED AS THE PAD WAS DEFECTIVE." "THESE PADS ARE DISPOSABLE UNITS THAT ARE GOOD FOR 14 DAYS." (SIC) DISCUSSION WITH FACILITY ON ORIGINAL MONTH, WITH SAFETY OFFICER STATED THAT THE DISPOSABLE PAD HAD A WOBBLY CORD, AND THAT THEY DISCARDED THE UNIT. THEREFORE, PRODUCT WAS UNAVAILABLE FOR TESTING BY MFR. NO REPORTS WERE COMPLETED BY FACILITY. SUSPECT PRODUCT IS THE DISPOSABLE PT-SPECIFIC 14 DAY BED PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TABS DISPOSABLE 14 DAY BED PAD KMI STANLEY-SENIOR TECHNOLOGIES SUSPECT #26300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other