BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETURN 7500I

    MDR report key: 7584763 · Received June 8, 2018

    Report

    Report Number
    3009481053-2018-00024
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    October 1, 2016
    Report Date
    April 10, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERNAL INVESTIGATION INDICATES THAT THE EVENT WAS MOST LIKELY CAUSED BY USING A RECALLED PRODUCT IN THE FILED. THE CUSTOMER LOCATED OUTSIDE OF UNITED STATES IN A FOREIGN COUNTRY DID NOT RESPOND TO THE RECALL NOTIFICATION AND CONTINUED TO USE THE PRODUCT. AFTER THE INCIDENT THE CUSTOMER WAS INFORMED TO REMOVE THE PRODUCT FROM USE. HANDICARE AB AS A MANUFACTURER SEES NO FURTHER ACTIONS, BUT WILL CONTUNE TO MONITOR THIS TYPE OF INCIDENTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A TRANSFER, THE RISING LADDER BROKE ON BOTH SIDES. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426669 RETURN 7500I PATIENT LIFTS FSA HANDICARE AB 7335

    Patients

    Seq Age Sex Outcome Treatment
    1