BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSBOND PLUS SELF ETCHING PRIMER

    MDR report key: 479534 · Received August 22, 2003

    Report

    Report Number
    2020467-2003-00003
    Event Type
    Injury
    Date Received
    August 22, 2003
    Date of Event
    August 12, 2003
    Report Date
    August 12, 2003
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIC ASSISTANT SAID THAT THEY WERE BENDING THE APPLICATOR AS THEY REMOVED IT FROM THE PACKAGE, WHICH RESULTED IN A SPRING ACTION OF THE APPLICATOR SO THAT SOME OF THE PRIMER FLEW INTO THEIR RIGHT EYE. (THEY WERE NOT WEARING SAFETY GLASSES). THEY IMMEDIATELY RINSED THEIR EYE WITH LARGE AMOUNTS OF WATER. ORTHODONTIC ASSISTANT STATED THAT A PHYSICIAN PRESCRIBED BLEPHAMIDE (A TOPICAL ANTI-INFLAMMATORY/ANTI-INFECTIVE WHICH IS INDICATED WHEN THE RISK OF SUPERFICIAL OCULAR INFECTION IS HIGH) FOR THEIR EYE. ORTHODONTIC ASSISTANT SAID THAT THEIR EYE FEELS FINE AND THERE ARE NO AFTER-EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSBOND PLUS SELF ETCHING PRIMER ORTHODONTIC PRIMER DYH 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention NOT APPLICABLE.