BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETCH GEL 40%

    MDR report key: 3357464 · Received September 11, 2013

    Report

    Report Number
    1721729-2013-00002
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    July 29, 2013
    Report Date
    September 10, 2013
    Product Code
    KLE
    PMA / PMN Number
    K030743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT CONTAINS 37% PHOSPHORIC ACID IN A GEL FORM. THE RETURNED ETCHANT WAS TESTED AND THE ACCOMPANYING INSTRUCTIONS WERE REVIEWED. THE ETCH GEL REQUIRED 3.2 ML OF 0.2 N NAOH TO REACH ENDPOINT DURING TITRATION WHICH CONFORMS TO THE SPEC (SPECIFICATION 3.0 - 3.5 ML). THE DIRECTIONS ALSO SPECIFY WARNINGS TO AVOID CONTACT WITH ORAL SOFT TISSUE AND DO NOT USE ON INDIVIDUALS WITH ALLERGIES.

    Description of Event or Problem · 1

    (B)(4). INITIAL INFO RECEIVED ON (B)(6) 2013. THE DENTIST REPORTED THAT A (B)(6) FEMALE PT, WITH NO SPECIFIED MEDICAL HISTORY WAS TREATED WITH ETCH GEL 40% (ETCH GEL 40%) ON (B)(6) 2013 IN AN UNK DENTAL PROCEDURE. ON (B)(6) 2013, THE DENTIST REPORTED THAT HE BURNED THE PT'S LIP AND PT HAD TO BE TRANSFERRED TO A DERMATOLOGIST. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456657 ETCH GEL 40% ETCH GEL 40% KLE L1411-2

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention