BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN

    MDR report key: 2879244 · Received December 12, 2012

    Report

    Report Number
    3006459587-2012-00010
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    END USER WAS USING THE ROLLATOR WHEN SHE APPLIED THE BRAKES TO SIT DOWN. THE UNIT MOVED AWAY AND THE END USER FELL AND HIT HER HEAD. END USER WAS HOSPITALIZED AND IS CURRENTLY IN REHAB. THE ROLLATOR INVOLVED IN THIS INCIDENT WAS RETURNED TO MEDLINE BY THE DEALER AND WAS INVESTIGATED BY A MEDLINE EMPLOYEE. THE FINDINGS ARE AS FOLLOWS: "THE SAMPLE WAS IN USED CONDITION. THERE WERE SCRAPES ALONG THE FRONT CROSSBAR AND DUST PRESENT THROUGHOUT THE ROLLATOR. THE BRAKES WERE SET AT THE 3RD ADJUSTMENT HEIGHT. BOTH BRAKES WERE OUT OF ADJUSTMENT. THE LEFT BRAKE WAS ADJUSTED SO THAT THE WHEEL COULD NOT TURN FREELY, WHILE THE RIGHT BRAKE DID NOT CATCH AT ALL WHEN THE BRAKE WAS APPLIED. UPON FURTHER INVESTIGATION IT WAS FOUND THAT THE BRAKE HANDLE WAS MISSING ONE SCREW, THEREBY NOT ALLOWING IT TO CATCH THE WHEEL PROPERLY WHEN THE DOWN FUNCTION WAS APPLIED. THIS IS A LACK OF MAINTENANCE ISSUE AND NOT A MFR DEFECT." THE MEDLINE EMPLOYEE STATED IN THE REPORT THAT THE ROLLATOR WOULD BE FORWARDED TO SUNRISE MEDICAL (US) LLC FOR INVESTIGATION. IF/WHEN THE ROLLATOR IS REC'D, IF ANY NEW INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN GUARDIAN ROLLATOR ITJ SUNRISE MEDICAL (US) LLC. G07887R 07110013

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization