BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 4051844 · Received August 7, 2014

    Report

    Report Number
    2438477-2014-00009
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    October 21, 2013
    Report Date
    July 7, 2014
    Manufacturer
    APEX HEALTH CARE MFG, INC.
    Product Code
    FSA
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS RECEIVED A LETTER FROM CLAIMANT'S ATTORNEY ON AN INCIDENT INVOLVING A MANUAL HYDRAULIC PT LIFT IMPORTED AND DISTRIBUTED BY DRIVE MEDICAL. THE CLAIMANT'S ATTORNEY STATED THAT THE PT HAS BEEN USING THIS LIFT TO RAISE HIMSELF. ON THE DATE OF EVENT, THE "S" HOOK OF THE CHAIN ALLEGEDLY BROKE CAUSING HIM TO FALL AND SUSTAIN INJURY. AN AMBULANCE WAS CALLED AND TRANSPORTED THE PT TO THE HOSPITAL. ACCORDING TO THE AMBULANCE ASSESSMENT, THE PT HAD "PAIN WITHOUT DEFORMITY IN L HIP, NO OTHER TRAUMA NOTED." HOWEVER ACCORDING TO THE ATTORNEY LETTER, THE PT WAS HOSPITALIZED AS A RESULT OF THE INCIDENT. THE ATTORNEY REFUSED TO PROVIDE DETAILS AND THE REASON FOR PT'S HOSPITALIZATION. THIS MDR REPORT IS BASE ON THE INFORMATION PROVIDED BY THE CLAIMANT AND HIS ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466195 DRIVE MEDICAL LIFT, PATIENT, NON-AC-POWERED FSA APEX HEALTH CARE MFG, INC. 13010SV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization