BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGIBLE BOOST

    MDR report key: 22038682 · Received May 16, 2025

    Report

    Report Number
    MW5170501
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    May 13, 2025
    Report Date
    May 13, 2025
    Manufacturer
    TANGIBLE SCIENCE
    Product Code
    QMM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TANGIBLE BOOST ((B)(6)). FOLLOWING THE PURCHASE OF AN EXPIRED TANGIBLE BOOST BOX, AND SUBSEQUENTLY REPORTING THE ISSUE TO THE MANUFACTURER/VENDOR, INITIATED A CHANGE TO THE PRODUCT'S SHELF LIFE ITSELF, SAYING IT'S SHELF LIFE WILL FROM NOW BE EXTENDED FROM 12 MONTH TO 30MONTH, WITHOUT PROVIDING ANY SORT OF OFFICIAL OR FDA (FOOD AND DRUG ADMINISTRATION)-STAMPED PROOF OF EXTENSIVE CHANGE CONTROL STABILITY TEST RESULTS SUPPORTING THE LEGITIMATE ALTERATION OF THIS ENTIRE LINE OF PRODUCT'S SHELF LIFE. ONLY A BRIEF AND SHORT MEMO PDF REPORT (TANGIBLE BOOST SHELF LIFE EXTENDED_(B)(4)) WAS PROVIDED TO ME OVER EMAIL. I WAS EXPECTING SOME MORE EXTENSIVE RISK EVALUATION STUDY REPORT WAS EXPECTED FOR FDA-REGULATED PRODUCT BEFORE UNDERGOING SUCH A SENSITIVE ALTERATION OF AN OFFICIAL'S PRODUCT'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166764 TANGIBLE BOOST HYDROPHILIC RE-COATING SOLUTION QMM TANGIBLE SCIENCE KEM084

    Patients

    Seq Age Sex Outcome Treatment
    1 Male