BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERA

    MDR report key: 2824116 · Received October 4, 2012

    Report

    Report Number
    9681684-2012-00072
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJO MED (B)(4). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED (B)(4). AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4). AN ON-SITE VISIT IS TO BE SCHEDULED TO HAVE THE DEVICES INVOLVED INSPECTED BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    PRELIMINARY INFORMATION REPORTED BY THE CUSTOMER IS THAT DURING A TRANSFER, A PT HAS FALLEN OUT OF A FLOOR LIFT USED WITH A CLIP SLING, BECAUSE ONE OF THE CLIP HAS COME LOOSE. THE PT SUSTAINED A BROKEN CLAVICLE AND SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB LTD KPB35

    Patients

    Seq Age Sex Outcome Treatment
    1 Other