BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISO-FORM CROWNS

    MDR report key: 681667 · Received March 2, 2006

    Report

    Report Number
    2110898-2006-00003
    Event Type
    Injury
    Date Received
    March 2, 2006
    Date of Event
    February 3, 2006
    Report Date
    February 7, 2006
    Manufacturer
    3M ESPE DENTAL PRODUCTS DIV
    Product Code
    ELZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED ANAPHYLACTIC SHOCK THAT BEGAN APPROX 6 HRS AFTER PLACEMENT OF THE ISO-FORM TEMPORARY CROWN. IT WAS REPORTED THAT THE PT NEEDED MED INTERVENTION WHICH INCLUDED ADMIN OF ANTIHISTAMINE AND ADRENALINE. AT THE TIME 3M ESPE AG WAS MADE AWARE OF THE INCIDENT, THE PT WAS REPORTED AS FINE, BUT TAKING MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISO-FORM CROWNS PREFORMED CROWNS ELZ 3M ESPE DENTAL PRODUCTS DIV NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R