BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRX CUSHION

    MDR report key: 24562595 · Received March 10, 2026

    Report

    Report Number
    9615350-2026-00002
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 10, 2026
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    IMP
    UDI-DI
    07540147000073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MENTIONED PRODUCT WAS SHIPPED BY MOTION CONCEPTS LP TO MEDBLOC ON (B)(6) 2025, IN ACCORDANCE WITH DEALER REQUIREMENTS. THE PRODUCT WAS SUBSEQUENTLY SOLD BY MEDBLOC TO NUMOTION, (B)(6). UPON RECEIVING NOTIFICATION OF THE ALLEGED INCIDENT, MOTION CONCEPTS REQUESTED ADDITIONAL DETAILS, INCLUDING PHOTOGRAPHS, AND REQUESTED THAT THE AFFECTED MATRX BACK SUPPORT BE RETURNED FOR EVALUATION. MOTION CONCEPTS MADE SIX FOLLOW-UP ATTEMPTS WITH THE DEALER TO OBTAIN THE REQUESTED INFORMATION AND PRODUCT RETURN, INCLUDING THREE EMAIL COMMUNICATIONS AND THREE PHONE CALLS. THE DEALER DID NOT RESPOND TO THESE REQUESTS. MOTION CONCEPTS SUBSEQUENTLY INVOLVED THE REGIONAL SALES REPRESENTATIVE TO ASSIST IN OBTAINING THE NECESSARY INFORMATION TO VERIFY AND EVALUATE THE ISSUE. THE SALES REPRESENTATIVE LATER INDICATED THAT THE END-USER HAD REPLACED THE ORIGINAL CUSHION WITH A THIRD-PARTY CUSHION. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING PHOTOGRAPHS OF THE ALLEGED INJURY OR IMAGES OF THE CUSHION INSTALLED ON THE THIRD-PARTY WHEELCHAIR. AS A RESULT, THE INVESTIGATION HAS BEEN CONDUCTED BASED ON THE LIMITED CUSTOMER-PROVIDED INFORMATION AND AVAILABLE HISTORICAL DATA. A REVIEW OF COMPLAINT RECORDS DETERMINED THAT THIS IS THE FIRST REPORTED INCIDENT OF THIS NATURE INVOLVING THE MATRX VI CUSHION. IT IS POSSIBLE THAT THE END-USER'S MEDICAL CONDITION MAY HAVE CONTRIBUTED TO LOCALIZED PRESSURE, WHICH COULD POTENTIALLY RESULT IN A PRESSURE SORE. ADDITIONALLY, IT IS ONLY POSSIBLE THAT THE PRESCRIBED CUSHION MAY NOT HAVE BEEN OPTIMAL FOR THE SPECIFIC NEEDS OF THE END-USER. HOWEVER, DUE TO THE LACK OF PRODUCT RETURN AND INSUFFICIENT INFORMATION FOR EVALUATION, MOTION CONCEPTS IS UNABLE TO CONFIRM THE ROOT CAUSE OF THE ALLEGED INJURY OR RECOMMEND ALTERNATIVE PRODUCT SOLUTIONS. THE CUSTOMER HAS NEITHER PLACED A REPLACEMENT ORDER NOR AGREED TO RETURN THE PRODUCT FOR CREDIT. MOTION CONCEPTS HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR EVALUATION. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA WITH THE FINDINGS. BASED ON THE CURRENTLY AVAILABLE INFORMATION, MOTION CONCEPTS CANNOT CONFIRM THAT THE INCIDENT RESULTED FROM A PRODUCT MALFUNCTION. HOWEVER, BECAUSE A PERSONAL INJURY WAS ALLEGED, THE EVENT IS CONSIDERED REPORTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, MEDBLOC (THE DISTRIBUTOR) NOTIFIED MOTION CONCEPTS LP OF AN INCIDENT INVOLVING A MATRX CUSHION INSTALLED ON A THIRD-PARTY WHEELCHAIR. ACCORDING TO THE INFORMATION PROVIDED, THE CUSHION HAD BEEN SOLD TO NUMOTION, WATSONVILLE, CA, WHO IS RESPONSIBLE FOR ITS ONGOING MAINTENANCE. THE DEALER REPORTED THAT THE END USER DEVELOPED A STAGE 1 PRESSURE SORE LOCATED AT THE CENTER OF HIS BOTTOM AFTER USING THE MATRX CUSHION. THE END USER APPLIED PATCHES INTENDED FOR PRESSURE SORE AND MONITORED THE CONDITION. THE CUSHION WAS REPLACED WITH A DIFFERENT CUSHION, AFTER WHICH THE REDNESS RESOLVED. APPROXIMATELY ONE WEEK LATER, THE END USER TRIED THE MATRX CUSHION AGAIN AND EXPERIENCED THE SAME RESULT. THE CUSHION WAS SUBSEQUENTLY REPLACED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387711 MATRX CUSHION WHEELCHAIR COMPONENT IMP MOTION CONCEPTS LP MA2523-VI(MAWWDD-VI) 07540147000073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other