BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELF LATEX FREE ELASTICS

    MDR report key: 559010 · Received December 10, 2004

    Report

    Report Number
    2086211-2004-00530
    Event Type
    Injury
    Date Received
    December 10, 2004
    Date of Event
    November 9, 2004
    Report Date
    November 10, 2004
    Manufacturer
    DENTSPLY GAC
    Product Code
    ECI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED HIVES AFTER CONTACT WITH ELASTICS AS PART OF ORTHODONTIC TREATMENT, INDICATING A POSSIBLE ALLERGIC REACTION TO THE ELASTICS OR A COMPONENT. NO MEDICAL INTERVENTION WAS REPORTED BUT IT IS REASONABLE TO ASSUME FROM A MEDICAL PRESPECTIVE THAT, AT A MINIMUM, THE ELASTICS WERE REMOVED TO PREVENT WORSENING OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELF LATEX FREE ELASTICS INTRAORAL ELASTICS ECI DENTSPLY GAC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention