BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRX BACKS

    MDR report key: 20846116 · Received December 4, 2024

    Report

    Report Number
    9615350-2024-00005
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    June 6, 2024
    Report Date
    December 4, 2024
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    KNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LETTER NOTIFYING US OF THE INCIDENT DID NOT INCLUDE ANY DETAILS ABOUT THE ALLEGED MATRX BACK, MAKING IT IMPOSSIBLE FOR US TO CONFIRM OR EVALUATE THE ISSUE. WE REQUESTED ADDITIONAL INFORMATION FROM THE LAWYER WHO NOTIFIED THE INCIDENT, HOWEVER, THEY ONLY PROVIDED THE SERIAL NUMBER OF THE THIRD-PARTY WHEELCHAIR, WHICH OFFERED NO RELEVANT DETAILS ABOUT THE ALLEGED MATRX BACK. MOTION CONCEPTS MATRX BACK (CLASS I WHEELCHAIR COMPONENT) WAS INSTALLED BY THIRD-PARTY DEALER. FOLLOWING FURTHER INQUIRIES, THE LAWYERS SHARED PHOTOGRAPHS OF THE DAMAGED PRODUCT, INCLUDING THE WHEELCHAIR INVOLVED IN THE INCIDENT. UPON REVIEWING THESE IMAGES, WE DETERMINED THAT THE MATRX BACK SHOWED NO SIGNS OF MALFUNCTION OR DAMAGE. INSTEAD, THE PICTURES REVEALED THAT THE BACK CANES OF THE WHEELCHAIR, WHICH ARE COMPONENTS OF THE HELIO C2 HD WHEELCHAIR (MANUFACTURED BY A THIRD PARTY), WERE BROKEN, LEADING TO THE INCIDENT. THIS INCIDENT WAS NOT CAUSED BY A MALFUNCTION OF A MOTION CONCEPTS PRODUCT BUT RATHER BY A FAILURE IN THE THIRD PARTY-MANUFACTURED WHEELCHAIR. SINCE PERSONAL INJURY OCCURRED, WE CONSIDER THIS INCIDENT REPORTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, (B)(6) LAW FIRM NOTIFIED MOTION CONCEPTS LP ABOUT AN INCIDENT INVOLVING ONE OF OUR MATRX BACKS. ACCORDING TO THE LETTER, THE MATRX BACK HAD BEEN SOLD TO ESSENTIAL HOME CARE PRODUCTS INC., WHICH INSTALLED IT ON A HELIO C2 HD WHEELCHAIR(THIRD-PARTY). THIS HELIO C2 HD WHEELCHAIR, MANUFACTURED BY A DIFFERENT COMPANY, WAS BEING USED BY THE END-USER AT THE TIME OF THE INCIDENT. THE LETTER STATED THAT ON (B)(6) 2024, WHILE THE END-USER WAS USING THE WHEELCHAIR, THE BACKREST SUDDENLY FAILED, CAUSING HIM TO FALL BACKWARD AND HIT HIS HEAD ON THE ASPHALT. THE FALL RESULTED IN A CONCUSSION, AND AS OF (B)(6) 2024, THE END-USER WAS REPORTEDLY EXPERIENCING VARIOUS CONCUSSIVE SYMPTOMS, INCLUDING COGNITIVE IMPAIRMENT, MEMORY LOSS, HEADACHES, PHOTOPHOBIA, AND PHONOPHOBIA. ADDITIONALLY, THE LETTER INDICATED THAT THE END-USER WAS SUFFERING FROM SOFT TISSUE INJURIES TO THE NECK AND SHOULDER. HOWEVER, NO SPECIFIC INFORMATION ABOUT THE ALLEGED MATRX BACK WAS INCLUDED IN THE LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227629 MATRX BACKS WHEELCHAIR KNN MOTION CONCEPTS LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other