BEUDAMED
    FDA Adverse Event Summary report: N

    MEDCARE

    MDR report key: 2820442 · Received October 10, 2012

    Report

    Report Number
    2135150-2012-00011
    Date Received
    October 10, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDCARE PRODUCTS INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE AT MEDCARE, ARE UNSURE HOW THE COTTER PIN WAS ABLE TO SHEAR AS IT DID. WE ARE ATTEMPTING TO DUPLICATE THE SCENARIO IN HOUSE. SO FAR WE HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    DURING A TRANSFER USING A MEDCARE LIFT N' WEIGH WITH THE ASSISTANCE OF ONE CNA, A RESIDENT WAS DROPPED. THE RESIDENT FELL WITH HER LEGS OUT IN FRONT OF HER AND LANDED ON HER BOTTOM. THE RESIDENT DID NOT COMPLAIN OF PAIN. THE RESIDENT WAS ACTING DIFFERENTLY AND DID NOT WANT TO SIT IN HER CHAIR OR SIT UP IN BED. THE RESIDENT WAS TAKEN TO THE EMERGENCY ROOM FOR X-RAYS, THE RESULTS CAME BACK NEGATIVE. THE RESIDENT HAS BEEN STEADILY IMPROVING. THE REASON FOR THE INCIDENT IS THE HANGER BAR BOLT CAME OUT OF THE LOAD CELL CAUSING THE RESIDENT TO DROP. THE FACILITY WENT BACK THE LOAD CELL/HANGER BAR ASSEMBLY BACK TO MEDCARE FOR FURTHER INVESTIGATION. THE INVESTIGATION SHOWED THAT THE COTTER PIN HAD BEEN SHEARED AS FRAGMENTS COULD BE SEEN IN THE PIN HOLE. ALSO, RED LOCTITE WAS PRESENT WHICH SHOWS US THAT THE LOAD CELL HAD BEEN PROPERLY ASSEMBLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCARE LIFT N' WEIGH FNG MEDCARE PRODUCTS INC. 400003

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization