BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETCH GEL 40%

    MDR report key: 3417868 · Received October 15, 2013

    Report

    Report Number
    1721729-2013-00003
    Event Type
    Injury
    Date Received
    October 15, 2013
    Date of Event
    January 2, 2013
    Report Date
    October 11, 2013
    Manufacturer
    SEPTODONT CONFIDENTAL DIV.
    Product Code
    KLE
    PMA / PMN Number
    K030743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT CONTAINS (B)(4) IN A GEL FORM. THE RETURN SAMPLE WAS EVALUATED. THERE WAS NO EVIDENCE OF MATERIAL LEAKING OR EXITING OUT OF EITHER SYRINGE. THE EXTRUSION FORCE OF THE MATERIAL FROM THE SYRINGE WAS FOUND TO BE WITHIN THE REQUIRED SPECIFICATION. THIS SHOWS THAT THE FLOW OF THE MATERIAL WAS SMOOTH AND REGULAR, WITH NO INCREASES IN THE CURVE TO INDICATE ANY "CLOGGING" IN THE SYRINGE. ADDITIONALLY, THE THREAD LOCK MECHANISM ON THE SYRINGES WAS TESTED, NO FAILURE WAS DETECTED.

    Description of Event or Problem · 1

    (B)(4). INITIAL INFO RECEIVED ON (B)(6) 2013. THE DENTIST REPORTED THAT A FEMALE PT, WITH NO SPECIFIED MEDICAL HISTORY HAD BEEN TREATED WITH ETCH GEL 40% (ETCH GEL 40%). WHILE SHE WAS FILLING THE SYRINGE THE DENTAL ASSISTANT RECEIVING A PROJECTION OF THE PRODUCT DIRECTLY IN THE EYE (PHOSPHORIC ACID 40%). THE ASSISTANT WENT THROUGH 3 SURGICAL OPERATIONS BUT UNFORTUNATELY DIDN'T RECOVER VISION. ANOTHER ONE IS PLANNED TOMORROW. ON (B)(6) 2013, THE PT EXPERIENCED EYE INJURY. THE PT HAD NOT YET RECOVERED. NO MORE INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528322 ETCH GEL 40% ETCH GEL 40% KLE SEPTODONT CONFIDENTAL DIV. 12401-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability