BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARISA

    MDR report key: 2104991 · Received April 14, 2011

    Report

    Report Number
    9611530-2011-00030
    Event Type
    Other
    Date Received
    April 14, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MFG, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG 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 MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HOSP EQUIPMENT AB AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING A PT TRANSFER, THEY REPORTEDLY DETACHED THE SLING CLIP WITH THEIR FOOT (INADVERTENTLY) AND FELL. THEY HIT THEIR HEAD ON THE FLOOR, HOWEVER, THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARISA PASSIVE FLOOR LIFT FSA ARJO MED AB LTD. KGA0200

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other