BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERITS VISION SPORT POWER WHEELCHAIR

    MDR report key: 17412667 · Received July 28, 2023

    Report

    Report Number
    9680333-2023-00002
    Event Type
    Death
    Date Received
    July 28, 2023
    Date of Event
    April 8, 2023
    Report Date
    May 2, 2023
    Manufacturer
    MERITS HEALTH PRODUCTS CO. LTD.,
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MENTIONED PRODUCT IN REPORT #: (B)(4), THE PLEURX BOTTLE & PLEURX DRAINAGE SYSTEM, IS MADE BY MERIT MEDICAL SYSTEMS (FDA REGISTRATION #: 3010665433), NOT BY MERITS HEALTH PRODUCTS INC. (FDA REGISTRATION #: 1058069). THE REPORTER HAS LINKED THE MENTIONED PRODUCT TO THE WRONG MANUFACTURER. THEREFORE, MERITS HEALTH PRODUCTS INC. WILL NOT TAKE ANY FURTHER ACTION OR FOLLOW-UP REGARDING THIS MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: DEFECTIVE. (B)(6) 2023 CALLED CUSTOMER TO FOLLOW UP ON REPORTED ISSUE. SPOKE WITH HUSBAND WHO ADVISED OF THE FOLLOWING DETAILS BELOW. HE EXPLAINED THAT CUSTOMER PASSED SOMETIME BETWEEN THE NIGHT BEFORE EASTER AND EASTER DAY. CUSTOMER DID NOT HAVE ANY ISSUES WITH PLEURX BOTTLE, OCCASIONALLY HAD ISSUES ONLY WITH THE ADHESIVE BEING SCRUNCHED UP TOGETHER BUT THEY WERE ABLE TO FLATTEN THEM OUT AND USE THEM WITHOUT ANY ISSUES. HUSBAND IS MILITARY AND PART OF SPECIAL OPERATIONS AND HAS EXTENSIVE MEDICAL TRAINING. HUSBAND ADVISED THE PLEURX DRAINAGE SYSTEM WAS EASY TO USE AND THE PATIENT DIED FROM STAGE 4 CANCER, THE DEATH WAS IN NO WAY CAUSED BY THE PLEURX PRODUCT. THERE WAS NO PT IMPACT AND NOTHING TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919878 MERITS VISION SPORT POWER WHEELCHAIR WHEELCHAIR, POWERED ITI MERITS HEALTH PRODUCTS CO. LTD., P326A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown