BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2140570 · Received June 16, 2011

    Report

    Report Number
    1525712-2011-00262
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    R. POON
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(6) CLAIMS MANAGER ALLEGES THE CONSUMER IS SEEKING ON-GOING TREATMENT AFTER THE ROLLATOR'S BACK LEFT WHEEL BROKE INTO TWO PIECES, CAUSING THE CONSUMER TO FALL. MAINTENANCE HISTORY IS UNKNOWN. PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION, SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER PURCHASED THE ROLLATOR ON (B)(6) 2010. SHE WAS USING THE ROLLATOR IN THE SCOPE OF HER EMPLOYMENT AT (B)(6) WHEN THE BACK LEFT WHEEL ALLEGEDLY BROKE IN TWO PIECES, CAUSING HER TO FALL. NO DETAILS OR DESCRIPTION OF THE ALLEGED INJURIES ARE KNOWN AT THIS TIME. THE COMPLAINT ALLEGES THE TREATMENT IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE ITJ R. POON QITEM RP090525

    Patients

    Seq Age Sex Outcome Treatment
    1