BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFTING POLE & HANDLE ASSY

    MDR report key: 1882873 · Received October 15, 2010

    Report

    Report Number
    3003984900-2010-00008
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING THE INCIDENT BECAUSE OF A POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. WE WILL BE SUBMIT A FOLLOW UP IN DUE COURSE GIVING DETAILS OF OUR ACTIONS.

    Description of Event or Problem · 1

    WE HAVE RECEIVED A REPORT FROM OUR (B)(4) SUBSIDIARY THAT A CUSTOMER HAS REPORTED TO THE (B)(4) THAT THE ROLKO STRAP AND HANDLE THAT WE SUPPLY AS PART OF THE BED ACCESSORY (B)(4) LIFTING POLE AND HANDLE ASSY HAS BROKEN ON THE ADJUSTABLE STRAP HOUSING; THE BREAKAGE OCCURRED WHEN THE PATIENT WAS LIFTING HIMSELF UP USING THE HANDLE. A MINOR INJURY WAS SUSTAINED (BUMP ON THE HEAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFTING POLE & HANDLE ASSY BED ACCESSORY FNL ARJOHUNTLEIGH ENT-ACC01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other