BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 2072674 · Received April 21, 2011

    Report

    Report Number
    2428983-2011-00001
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    January 13, 2011
    Report Date
    April 21, 2011
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT CO, LTD
    Product Code
    ITJ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER/CLAIMANT IS REPRESENTED BY AN ATTORNEY. GF HEALTH PRODUCTS, INC. HAS RECEIVED DIGITAL PICTURES OF THE ROLLATOR. THE CLAIMANT'S ATTORNEY WILL CONSIDER SHIPPING THE ROLLATOR TO OUR QUALITY ANALYST FOR AN INDEPENDENT 3RD PARTY EVAL ONCE SHE HAS HAD THE PRODUCT PROFESSIONALLY PHOTOGRAPHED AND ANALYZED BY A SPECIALIST. DIGITAL PICTURES HAVE BEEN FORWARDED TO THE MFR FOR A FAILURE MODE ANALYSIS. MDR FILED BASED ON THE ALLEGED INJURY. NO MEDICAL SUBSTANTIATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    CLAIMANT'S ATTORNEY STATED ON (B)(6) 2011, THAT THE END-USER WAS SITTING ON HER WALKER OUTSIDE OF HER HOME WHEN THE LEG OF THE WALKER SUDDENLY BROKE. SHE FELL TO THE GROUND, HITTING HER HEAD AND LEFT SHOULDER. THE 911 WAS CALLED AND SHE WAS TRANSPORTED TO THE HOSPITAL. SURGERY WAS PERFORMED ON HER LEFT SHOULDER. FOLLOWING THE SURGERY SHE STAYED IN A REHABILITATION CENTER UNTIL THE END OF MARCH AND THEN RETURNED TO HER RESIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX ROLLATOR ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT CO, LTD FJ4300B MRM105MO3289

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R