BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESTHET-X

    MDR report key: 337471 · Received June 14, 2001

    Report

    Report Number
    2515379-2001-00009
    Event Type
    Other
    Date Received
    June 14, 2001
    Date of Event
    May 21, 2001
    Manufacturer
    L.D. CAULK
    Product Code
    ELR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DENTAL PATIENT ALLEGEDLY EXPERIENCED A POSSIBLE ALLERGIC REACTION CONSISTING OF TISSUE REACTION, BLISTERS, AND A SWOLLEN FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27216 ESTHET-X DENTAL RESTORATIVE ELR L.D. CAULK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other