BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEN ACES MEDICAL ADHESIVE SPRAY

    MDR report key: 18060041 · Received November 1, 2023

    Report

    Report Number
    MW5147674
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 15, 2023
    Report Date
    October 23, 2023
    Manufacturer
    TEN ACES MED LLC
    Product Code
    GBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE CONDUCTED A TEST PURCHASE OF TEN ACES MEDICAL ADHESIVE REGISTRATION NUMBER (B)(4). THE PRODUCT WAS SHIPPED TO US WITHOUT THE REQUIRED HAZMAT SHIPPING LABELS, IN VIOLATION OF DOT AND USPS REGULATIONS. WE ALSO FOUND THAT THE PRODUCT WAS MISSING AN EXPIRATION DATE AND BATCH NUMBER. BASED ON THIS, AND OUR COMMUNICATIONS WITH THE MANUFACTURER, WE SUSPECT THEY MAY BE MANUFACTURING MEDICAL DEVICES WITHOUT A QUALITY MANAGEMENT SYSTEM. TEN ACES MEDICAL IS A NEW COMPANY AND MAY NOT UNDERSTAND THEIR DUTIES AS A MEDICAL DEVICE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961576 TEN ACES MEDICAL ADHESIVE SPRAY PROSTHESIS, ADHESIVE, EXTERNAL GBJ TEN ACES MED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown