BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER

    MDR report key: 5717195 · Received June 10, 2016

    Report

    Report Number
    3007420694-2016-00107
    Event Type
    Injury
    Date Received
    June 10, 2016
    Report Date
    August 3, 2018
    Manufacturer
    APEX
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT HAS BEEN CREATED TO REMOVE THE INCORRECT DATA PROVIDED IN PREVIOUS REPORT. CORRECTION IS RELATED TO G1-G2 SECTION (CONTACT OFFICE-MANUFACTURING SIDE)- THE DATA PROVIDED IN THE PREVIOUS REPORT SHOULD BE DELETED.

    Additional Manufacturer Narrative · 1

    WE ARE FORWARDING INFORMATION ABOUT THIS ADVERSE EVENT FOLLOWING REGULATION UNDER 21 C.F.R. 803.22.2(B). ON MAY 13TH 2016, ARJOHUNTLEIGH (B)(4) (FORMERLY BHM MEDICAL INC.) WAS MADE AWARE OF THE ALLEGATION THAT A FLOOR LIFT MANUFACTURED BY BHM MEDICAL HAD BEEN INVOLVED IN AN ADVERSE EVENT. THE NOTIFICATION WAS MADE BY LETTER, TRANSMITTED TO ARJOHUNTLEIGH (B)(4) BY (B)(4) INSURANCE GROUP REPRESENTING JOERNS WOUNDCO HOLDINGS, INC. IT WAS INDICATED THAT FOLLOWING THE INSPECTION OF THE ALLEGED LIFT, IT WAS CONFIRMED TO HAVE BEEN MANUFACTURED BY BHM MEDICAL INC. AT THAT TIME, ARJOHUNTLEIGH (B)(4) DID NOT RECOGNIZE THIS INFORMATION TO BE RELATED TO AN ARJOHUNTLEIGH (B)(4) DEVICE. ADDITIONAL FOLLOW-UP WAS MADE, WHICH PERMITS TO OBTAIN THE CONFIRMATION FROM (B)(4) INSURANCE GROUP THAT THE DEVICE INVOLVED WAS NOT MANUFACTURED BY ARJOHUNTLEIGH OR BHM MEDICAL. THE ORIGINAL EQUIPMENT MANUFACTURER HAS BEEN MADE AWARE OF THIS ADVERSE EVENT THEREFORE WE CONSIDER THIS CASE CLOSED.

    Description of Event or Problem · 1

    ON 05/13/2016 ARJOHUNTLEIGH HAS BEEN INFORMED OF AN ADVERSE EVENT CONCERNING HOYER LIFT MODEL HML400, WITH SERIAL NUMBER (B)(4), WHERE THE PART BROKE AND IN EFFECT THE RESIDENT SUSTAINED A BROKEN HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372509 HOYER FSA FSA APEX HML400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization