BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODE ALERT

    MDR report key: 96908 · Received June 6, 1997

    Report

    Report Number
    96908
    Event Type
    Injury
    Date Received
    June 6, 1997
    Date of Event
    June 1, 1997
    Report Date
    June 5, 1997
    Manufacturer
    R.F. TECHNOLOGIES, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT PLACED IN RECLINER WITH ALARM PAD IN PLACE & TURNED ON. ALARM PAD MONITOR BEEPED & LIGHT WAS BLINKING TO INDICATE IT WAS WORKING CALLED TO ROOM BY ANOTHER RESIDENT. INJURED RESIDENT FOUND LYING ON FLOOR. LACERATION TO RT. TEMPLE, COMPLAINS OF PAIN RT. HIP. TRANSFERRED VIA BOARD TO GURNEY TO GO TO E.R. FOR EVALUATION. ALARM DID NOT SOUND WHEN RESIDENT GOT OUT OF CHAIR. X-RAYS DONE IN E.R. ADMITTED TO HOSP FOR OBSERVATION AND EVALUATION TO RULE OUT RT. HIP AND FACIAL FRACTURE. NO FRACTURE DIAGNOSED BY RADIOLOGIST WHEN X-RAY READ (6/2/97).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODE ALERT ALARM-PAD KMI R.F. TECHNOLOGIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization PHENOBARBITOL 45MG QD, SYNTHOID 0.125MG QD,COLACEQ