BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 2870021 · Received December 10, 2012

    Report

    Report Number
    9681684-2012-00098
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH INC ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. NO DEFICIENCIES WERE FOUND WITH THE DEVICE. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS TRANSFERRED WHEELCHAIR TO TOILET USING A FLOOR FIT AND A TOILET SLING. THE RESIDENT WAS TRANSFERRED BACK TO THE WHEELCHAIR, AND WHILE THE CARER WAS STANDING BEHIND HER, THE RESIDENT SAID SHE SLIPPED AWAY, FALLING THROUGH THE TOILET SLING. THE CARER CATCHES HER WITH HER UPPER LEGS AND DECIDED TO HELP THE RESIDENT TO SLOWLY GO TO THE GROUND, BENDING HER OWN KNEES. EXTRA HELP WAS CALLED. RESIDENT SUSTAINED A BRUISE ON LEFT ARM AND CARER, BRUISE ON LEFT ARM AND MUSCLE PAIN IN BOTH LEGS. NO TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE MANUFACTURED FLOOR PASSIVE LIFT FSA ARJOHUNTLEIGH MAGOG INC. KMCSXE-D

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR