BEUDAMED
    FDA Adverse Event Summary report: N

    FLUOR PROTECTOR S

    MDR report key: 6257166 · Received January 17, 2017

    Report

    Report Number
    9612352-2017-00001
    Date Received
    January 17, 2017
    Date of Event
    November 22, 2016
    Report Date
    January 13, 2017
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    LBH
    PMA / PMN Number
    K131487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    A TOTAL OF 2 COMPLAINTS WERE RECEIVED: (B)(4) (CATALOG #639520AN, BATCH NO. (B)(4)) AND (B)(4) (CATALOG # 639521AN, NO BATCH #) FROM THE SAME DENTIST. THE TWO CATALOG NUMBERS ARE BOTH FOR FLUOR PROTECTOR S. CATALOG #639520AN IS FOR FLUOR PROTECTOR S REFILL 1X7G AND 639521AN IS FOR FLUOR PROTECTOR S REFILL 3X7G. THE FIRST EVENT ON (B)(6) 2016 ((B)(4)) OCCURED WHEN THE FLUOR PROTECTOR S TUBE BURST WHILE DISPENSING. THE DISPENSING TIP BECOME DISCONNECTED FROM THE TUBE AND THE MATERIAL SPLASHED ON THE ASSISTANT'S SAFETY/EYE GLASSES AND T-SHIRT. DURING THE SECOND EVENT ON (B)(6) 2016 ((B)(4), CATALOG # 639521AN) THE MATERIAL BURST OUT OF THE TUBE AND SPLASHED INTO THE ASSISTANTS EYES AND FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39992 FLUOR PROTECTOR S VARNISH, CAVITY LBH IVOCLAR VIVADENT AG V23022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other