BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCERTO, BASIC AND SHOWER TROLLEY

    MDR report key: 1849101 · Received September 24, 2010

    Report

    Report Number
    9611530-2010-00066
    Event Type
    Other
    Date Received
    September 24, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJO INC, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2010: "CONCERNS A PATIENT WITH HUNTINGTON DISEASE. THAT IS WHY THE MUSCLE STRENGTH WORKS AGAINST US. PATIENT WAS SHOWERED BY 2 CARERS IN HIS OWN BEDROOM. PATIENT WAS TRANQUIL. MORE POWER IS NEEDED TO GET THIS PATIENT ON HIS SIDE, TO DRY THE LEFT SIDE, PATIENT LAY AGAINST THE FENCE OF THE CONCERTO. CLIP GOT LOOSE ON LEFT HEADSIDE, FENCE WENT DOWN. PATIENT FELL DOWN BUT CARER COULD HELP HIM TO EASE THE FALL." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO, BASIC AND SHOWER TROLLEY LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB 084021-04

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR