BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCERA BASE

    MDR report key: 12804286 · Received November 10, 2021

    Report

    Report Number
    MW5105283
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    November 9, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ENVISIONTEC GMBH
    Product Code
    EBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE COMPANY MANUFACTURES CLASS 2 RESINS IN A SUB STANDARD FACILITY THAT IS NOT REMOTELY GMP. PICTURES ATTACHED. THE PRODUCT IS CLASSIFIED AND ADVERTISED AS HIGH IMPACT DENTURE MATERIAL. THE 510K NUMBER IS K203641. THE ISO TESTING REQUIRES THE MATERIAL TO BE TESTED IN WATER IN 48 HOURS. WE TESTED THE MATERIAL AND UNFORTUNATELY THE MATERIAL GETS COMPLETELY FLEXIBLE AND LOSES IT'S RIGIDITY IN WATER. THIS COULD DAMAGE AND HURT PEOPLE; 510K NUMBER: K203641. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683301 FLEXCERA BASE RESIN, DENTURE, RELINING, REPAIRING, REBASING EBI ENVISIONTEC GMBH FLEXCERA BASE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown