BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 2906099 · Received January 4, 2013

    Report

    Report Number
    2438477-2013-00002
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS RECEIVED A COMPLAINT FROM AN ASSISTED LIVING FACILITY ABOUT AN INCIDENT INVOLVING A HYDRAULIC PT LIFT ALLEGEDLY IMPORTED AND DISTRIBUTED BY (B)(4). IT IS ALLEGED THAT AN AIDE WAS MOVING THE PT WHEN THE TWO LEGS MOVED CLOSER CAUSING THE LIFT TO TIP AND THE PT TO FALL HITTING THE AIDE'S SHOULDER. THE PT ALLEGEDLY FELL ON THE FLOOR AND BROKE HER HIP. THE PT LIFT IS REPORTED AS A RENTAL ITEM AND HAD BEEN USED FOR LESS THAN A MONTH. THIS MDR IS BASED ON THE INFO PROVIDED BY THE ASSISTED LIVING FACILITY AND THE MEDICAL SUPPLIER WHO PROVIDED THE LIFT AT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5055 DRIVE MEDICAL PATIENT LIFT FSA SHENYANG HENYI ENTERPRISE CO LTD 13023SV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention