BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYTIN REGULAR SET SPHERICAL SILVER AMALGAM

    MDR report key: 137146 · Received August 14, 1997

    Report

    Report Number
    MW4002076
    Event Type
    Malfunction
    Date Received
    August 14, 1997
    Report Date
    August 4, 1997
    Manufacturer
    KERR CORP.
    Product Code
    DZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAPSULES ARE DISPENSING MERCURY DURING MIXING PROCEDURES, RECALLED ALL TYTIN AMALGAM FROM DENTAL TREATMENT ROOMS. DATE MANUFACTURED 03/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYTIN REGULAR SET SPHERICAL SILVER AMALGAM SILVER AMALGAM CAPSULE DZS KERR CORP. * 72055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA