BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 16672120 · Received April 4, 2023

    Report

    Report Number
    1419652-2023-00022
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    May 4, 2022
    Report Date
    April 4, 2023
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE MOBILIZING IN THE BATH USING AN ACTIVE LIFT, THE PATIENT RAISED THEIR ARMS, CAUSING THE PATIENT TO SLIP OUT OF THE SLING AND FALL. AS A CONSEQUENCE OF THE EVENT THE PATIENT SUSTAINED A LEFT ANTERIOR SHOULDER DISLOCATION. THE CUSTOMER REPORTED THAT THE PATIENT PASSED AWAY 20 DAYS AFTER THE EVENT, HOWEVER, THE CUSTOMER CONFIRMED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382431 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO MEDICAL PRODUCTS NV HEA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female Required Intervention