BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINUM TRANSPORT WHEELCHAIR

    MDR report key: 17914267 · Received October 11, 2023

    Report

    Report Number
    1531186-2023-00003
    Event Type
    Injury
    Date Received
    October 11, 2023
    Report Date
    September 13, 2023
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT CO LTD
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO GET FURTHER INFORMATION REGARDING THE EVENT, PICTURES OF THE DEVICE, HOW THE DEVICE WAS BEING USED, ANY FURTHER INJURY OR MEDICAL TREATMENT DETAILS, THE END USERS¿ WEIGHT, THE AGE OF THE DEVICE, DETAILS ABOUT THE SEAT POSITIONING STRAP AND IF THE STRAP WAS BEING USED AT THE TIME OF THE EVENT WITHOUT SUCCESS. THE CAUSE OF THE ISSUE OR IF THERE WAS A DEVICE MALFUNCTION HAS NOT BEEN CONFIRMED AT THIS TIME. A RETURN TRANSACTION FOR THE DEVICE TO BE RETURNED AND INSPECTED HAS BEEN ISSUED, HOWEVER THE DEVICE HAS NOT BEEN RETURNED AT THIS TIME. THIS DEVICE WAS SUPPLIED BY DANYANG MAXTHAI MEDICAL EQUIPMENT CO LTD, AND THEY WILL BE NOTIFIED OF THIS INCIDENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 0

    THE END USER WAS IN THEIR LTTR19FR TRANSPORT WHEELCHAIR WHEN IT BUCKLED. HE FELL BACK AND HIT HIS HEAD ON THE HOUSE WINDOW. THE END USER WENT TO THE HOSPITAL, AND THEY FOUND HE HAD A CONCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238259 ALUMINUM TRANSPORT WHEELCHAIR TRANSPORT CHAIR INM DANYANG MAXTHAI MEDICAL EQUIPMENT CO LTD NA:LTTR19FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization