BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOBAN GEL COMPLETE KIT

    MDR report key: 12148069 · Received July 9, 2021

    Report

    Report Number
    2515379-2021-00011
    Event Type
    Injury
    Date Received
    July 9, 2021
    Report Date
    July 22, 2021
    Manufacturer
    DENTSPLY CAULK
    Product Code
    MVL
    PMA / PMN Number
    K123215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT GUM TISSUE WAS "BURNED" AFTER USE OF HEMOBAN GEL. THE DENTIST STATED IT WAS PUT ON THE CORD AND IT HAPPENED WITHIN MINUTES OF USE. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037584 HEMOBAN GEL COMPLETE KIT CORD, RETRACTION MVL DENTSPLY CAULK NA BH99K

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other