BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETURN 7500I

    MDR report key: 7180561 · Received January 10, 2018

    Report

    Report Number
    3007802293-2018-00002
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    December 1, 2017
    Report Date
    January 22, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    IKX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERNAL INVESTIGATION INDICATES THAT THE EVENT WAS MOST LIKELY CAUSED BY EITHER OF THE FOLLOWING: 1. DEVICE LEG SUPPORTS MOUNTED AT WRONG HEIGHT, OR 2. ADJUSTMENT PINS OF LEG SUPPORTS NOT CORRECTLY SECURED BEFORE USE THE USER MANUAL CONTAINS INSTRUCTIONS ON HOW TO MOUNT THE DEVICE LEG SUPPORTS IN RELATION TO THE PATIENT'S KNEE HEIGHT AND TO ENSURE THAT ADJUSTMENT PINS ARE LOCKED INTO POSITION. HANDICARE AB SEES NO REASON FOR FURTHER ACTIONS, BUT WILL CONTINUE TO MONITOR THIS TYPE OF EVENT.

    Additional Manufacturer Narrative · 1

    OUTCOME OF INVESTIGATION PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    PATIENT SLIPPED FROM THE BASE PLATE ON A 7500I RETURN TRANSFER SYSTEM. THE PATIENT SUSTAINED A HIP FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24275 RETURN 7500I AID,TRANSFER IKX HANDICARE AB 7500I

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization