BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDCARE CARE STAND 350

    MDR report key: 11072008 · Received December 24, 2020

    Report

    Report Number
    3007802293-2020-00028
    Event Type
    Injury
    Date Received
    December 24, 2020
    Date of Event
    June 6, 2018
    Report Date
    January 15, 2021
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE NUMEROUS ATTEMPTS TO CONTACT THE FACILITY INVOLVED, FURTHER DETAILS WERE UNABLE TO BE OBTAINED. THEY DID STATE THAT THE INCIDENT INVOLVED UNITS WITH SERIAL NUMBERS OF (B)(6), MANUFACTURED IN FEB 2003 AND OCT 2010, RESPECTIVELY. IF THE STAND BELT IS SECURE AND PROPERLY PLACED WITH THE PATIENT'S KNEES AGAINST THE KNEE PADS AND THE PATIENT'S FEET ARE ON THE FOOT PLATE, HE OR SHE COULD BE LOWERED TO A SURFACE SAFELY EVEN IF UNCONSCIOUS. IT APPEARS THAT THE INCIDENT WAS NOT DUE TO A PRODUCT MALFUNCTION AND INSTEAD RELATED TO USER ERROR (NOT USING THE CORRECT SIZE BELT OR COMPLETING THE TRANSFER CORRECTLY). NO CORRECTION OR CORRECTIVE ACTION IS POSSIBLE AS WE WERE UNABLE TO COMMUNICATE WITH THE FACILITY SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING MORE DETAILS ABOUT THIS INCIDENT AND WILL FILE A FOLLOW-UP REPORT WHEN RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, HANDICARE WAS NOTIFIED OF AN INCIDENT IN WHICH A USER WAS BEING TRANSFERRED FROM A CHAIR TO A BED USING A MEDCARE STAND AID, BECAME UNCONSCIOUS, FELL TO THE FLOOR, AND BROKE BOTH FEMURS. THERE WAS NO REPORTED FAILURE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537144 MEDCARE CARE STAND 350 MOBILE LIFT FSA HANDICARE USA INC. 400002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention