BEUDAMED
    FDA Adverse Event Other Summary report: N

    CITRIZYME

    MDR report key: 2491124 · Received March 8, 2012

    Report

    Report Number
    3011632-2011-00001
    Event Type
    Other
    Date Received
    March 8, 2012
    Date of Event
    April 14, 2011
    Report Date
    May 9, 2011
    Manufacturer
    PASCAL CO., INC.
    Product Code
    MDZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PATIENT WAS GIVEN OUR POWDERED PRODUCT, CITRIZYME, A CLASS I MEDICAL DEVICE ENZYMATIC ULTRASONIC CLEANSER, MIXED IN A GLASS OF WATER BY THE DENTIST TO DRINK. PACKAGE LABELING FOR CITRIZYME CLEARLY STATES "NOT FOR HUMAN CONSUMPTION." ACCORDING TO THE DENTIST'S OFFICE, IT IS A STANDARD PRACTICE TO ADMINISTER TO THE PATIENT A PREPARED SOLUTION OF VITAMIN C TO DRINK. THE DENTIST MISTOOK A PACKET OF CITRIZYME FOR THE PACKET OF VITAMIN C. PATIENT CONTACTED OUR OFFICE FOR INFORMATION ABOUT THIS PRODUCT. WE INFORMED THE PATIENT OF THE CONTENTS, AND TO SEEK MEDICAL ATTENTION. AFTER SEVERAL ATTEMPTS TO CONTACT THE PATIENT, WE FINALLY SPOKE TO HER ON (B)(6) 2011. SHE CONFIRMED SHE WENT TO THE ER AND THEY "RAN A FEW BLOOD TESTS" AND CONTACTED POISON CONTROL. POISON CONTROL REPORTED TO THE HOSPITAL THAT NO PREVENTATIVE MEASURES NEEDED TO BE TAKEN WITH CITRIZYME. THE PATIENT COMPLAINED OF "FLU LIKE" SYMPTOMS FOR A FEW DAYS FOLLOWING INGESTION, BUT FEELS FINE NOW. (03/03/2012, PLEASE NOTE: THIS IS A RESUBMISSION OF THIS REPORT TO CORRECT MFR REPORT#).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CITRIZYME ULTRASONIC CLEANER (88.06150) (FLG) MDZ PASCAL CO., INC. 15250 090612

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention