BEUDAMED
    FDA Adverse Event Injury Summary report: N

    37% PHOSPHORIC ACID ETCH GEL

    MDR report key: 4438994 · Received January 21, 2015

    Report

    Report Number
    2024312-2015-00005
    Event Type
    Injury
    Date Received
    January 21, 2015
    Report Date
    January 9, 2015
    Manufacturer
    PENTRON CLINICAL
    Product Code
    KLE
    PMA / PMN Number
    K000954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE AND WEIGHT WAS NOT PROVIDED. THE DOCTOR REPORTED THAT THE 37% PHOSPHORIC ACID ETCH GEL HAD ACCIDENTALLY CONTACTED A PATIENT'S FACE DURING A PROCEDURE, AND THE DOCTOR WAS UNAWARE UNTIL A FEW MINUTES LATER WHEN THE PATIENT BEGAN TO FEEL A BURNING, ITCHING SENSATION. THE DOCTOR COMPLETED THE PROCEDURE, PRESCRIBED ALO-GEL FOR TREATMENT OF THE IRRITATION, AND DISMISSED THE PATIENT. THE PATIENT RETURNED TO THE OFFICE FOR A FOLLOW-UP VISIT AND INFORMED THE DOCTOR THAT THE AREA HAD BEEN PERMANENTLY SCARRED; HOWEVER, THE DOCTOR COULD NOT VISUALLY CONFIRM THIS AS THE PATIENT WAS WEARING MAKEUP AT THE TIME, AND SINCE THEN HAS NOT RETURNED TO THE OFFICE. THE DOCTOR COULD NOT VERIFY WHETHER ANY MEDICAL ATTENTION OR PRESCRIPTION MEDICATION WAS NECESSARY FOR TREATMENT. KERR CORPORATION HAS REQUESTED THAT THE CUSTOMER REPORT ANY NEW INFORMATION WITH REGARD TO THIS PATIENT. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE REPORTED THAT A PATIENT ALLEGED THAT SHE HAD EXPERIENCED A BURNING SENSATION, ITCHINESS, AND SCARRING AFTER THE 37% PHOSPHORIC ACID ETCH GEL MATERIAL HAD CONTACTED HER FACE DURING A BLEACHING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49116 37% PHOSPHORIC ACID ETCH GEL AGENT, TOOTH BONDING RESIN KLE PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R