BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARISA

    MDR report key: 2133911 · Received June 15, 2011

    Report

    Report Number
    9611530-2011-00047
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MANUFACTURED, 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 MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    FACILITY DNS STATED THAT THE CNAS HAD ATTACHED THE SLING CLIPS TO THE MARISA. THEY WERE USING A "NEW SLING" THAT WAS "STIFF COMPARED TO THE OLD ONES THEY HAD BEEN USING," AND THE CLIP "SLIPPED OFF OF THE LIFT" DURING A PT TRANSFER. THE DNS IDENTIFIED THAT THE CNAS "HAD NOT SECURED THE CLIP ON THE LIFT." THE PT SUFFERED A LACERATION TO THE HEAD THAT REQUIRED STITCHES TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARISA PASSIVE FLOOR LIFT FSA ARJO MED AB LTD KGB2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R