BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALENTI

    MDR report key: 1912877 · Received November 11, 2010

    Report

    Report Number
    9611530-2010-00110
    Event Type
    Other
    Date Received
    November 11, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION CO IN THE (B)(4).

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON (B)(6) 2010: "(B)(4) WITH PT FELL OVER CAUSE SAFETY BELT WAS MISSING". DESCRIPTION OF INCIDENT/COURSE OF EVENTS: "THE RESIDENT SLID FROM THE CHAIR DURING DRYING HIS HAIR AND THE LIFTER FELL OVER TO THE SIDE. THE CAREGIVER COULD PREVENT THE COLLISION ON THE FLOOR SO NOBODY WAS HURT. THE SAFETY BELT WAS MISSING." MANUFACTURER'S REF NO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB CDB8051-01

    Patients

    Seq Age Sex Outcome Treatment
    1