BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDCARE LIFT WITH SCALE

    MDR report key: 898131 · Received August 14, 2007

    Report

    Report Number
    2135150-2007-00007
    Event Type
    Other
    Date Received
    August 14, 2007
    Date of Event
    July 17, 2007
    Manufacturer
    MEDCARE PRODUCTS LLC
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN CONVERSATION WITH MAINTENANCE, THEY INDICATED THAT THERE WERE VISIBLE SIGNS OF WEAR AND TEAR ON THE HANGAR BARS BEFORE THE INCIDENT OCCURRED. THESE HANGAR BARS WERE OVER 10 YEARS OLD, AND HAD NEVER BEEN REPLACED BY THE FACILITY. THIS MACHINE WAS NOT MANUFACTURED BY US, MEDCARE PRODUCTS, INC. IT WAS MANUFACTURED AND SOLD BY AN UNRELATED COMPANY, MEDCARE PRODUCTS, LLC. MEDCARE PRODUCTS, INC PURCHASED THE ASSETS (NOT LIABILITIES) OF MEDCARE PRODUCTS, LLC IN MARCH OF 1998.

    Description of Event or Problem · 1

    DURING TRANSFER FROM BATHROOM TO BED, RESIDENT WAS BEING TRANSFERRED WITH A LIFT WHEN THE YOLK HANGAR BAR THAT IS ATTACHED TO THE LOAD CELL BROKE. ONE HOOK BENT AND BROKE OFF. THE RESIDENT FELL TO THE FLOOR AND HIT THEIR HEAD. THEY WERE TAKEN TO THE HOSPITAL EMERGENCY ROOM. NO FRACTURES OR OTHER INJURIES NOTED OTHER THAN A BUMP ON THEIR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCARE LIFT WITH SCALE PATIENT LIFT FSA MEDCARE PRODUCTS LLC 400003

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other