BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYBRALLOY CAPSULES

    MDR report key: 10921 · Received January 12, 1994

    Report

    Report Number
    MW1000373
    Event Type
    Malfunction
    Date Received
    January 12, 1994
    Report Date
    January 3, 1994
    Manufacturer
    KERR MFG CO.
    Product Code
    EJJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AMALGAM CAPSULES CONTAINED ONLY MERCURY. NO ALLOY POWDER IN AT LEAST SEVEN CAPSULES. MFR HAD BEEN NOTIFIED. NO F/U FROM SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBRALLOY CAPSULES EJJ KERR MFG CO. 600 MG FAST SET 082791

    Patients

    Seq Age Sex Outcome Treatment
    1 *