BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERA

    MDR report key: 2163462 · Received June 17, 2011

    Report

    Report Number
    9681684-2011-00043
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. AB LTD (UNDER REGISTRATION (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 BHM MEDICAL INC. AN ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE PERFORMING A BED TO CHAIR TRANSFER, STAFF RAISED THE RESIDENT OFF THE BED IN A RECLINED POSITION. WHILE APPROACHING THE CHAIR, ONE OF THE STAFF PULLED DOWN ON THE SPREADER BAR HANDLE TO PUT THE RESIDENT INTO A SEATED POSITION. THE RESIDENT THEN SLID OUT THE BOTTOM OF THE SLING, HER LEGS HITTING THE FLOOR AND THE LEFT SIDE OF HER HEAD HITTING THE LEG OF THE FLOOR LIFT. SHE WAS RUSHED TO THE HOSPITAL WHERE INTRACRANIAL BLEEDING WAS DIAGNOSED; DUE TO THE RESIDENT'S AGE, THE DOCTOR DECIDED TO NOT PERFORM SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| O