BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTI-FREE ENZYMATIC CLEANER

    MDR report key: 1030762 · Received April 17, 2008

    Report

    Report Number
    1610287-2008-00015
    Event Type
    Death
    Date Received
    April 17, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 10, 2008
    Manufacturer
    ALCON - FORT WORTH - ALCON LABORATORIES INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER HAS NOT PROVIDED A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. A REVIEW OF TOXICOLOGY DATA SHOWED THE PRODUCT HAD NO ORAL TOXICITY AT A LEVEL EQUIVALENT TO 64 TABLETS PER KG BODY WEIGHT WHEN ADMINISTERED TO RATS IN A SINGLE ORAL DOSE. THIS IS THE EQUIVALENT OF A 7-LBS INFANT CONSUMING 201.6 TABLETS. THE PRODUCT LABEL STATES: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM THE REPORTER.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER HAS NOT PROVIDED A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. A REVIEW OF TOXICOLOGY DATA SHOWED THE PRODUCT HAD NO ORAL TOXICITY AT A LEVEL EQUIVALENT TO 64 TABLETS PER KG BODY WEIGHT WHEN ADMINISTERED TO RATS IN A SINGLE ORAL DOSE. THIS IS THE EQUIVALENT OF A 7-LBS INFANT CONSUMING 201.6 TABLETS. THE PRODUCT LABEL STATES: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM THE REPORTER ON 04/10/2008, 04/11/2008, 04/14/2008 AND 04/15/2008.

    Description of Event or Problem · 1

    THE CHIEF INVESTIGATOR FROM THE MEDICAL EXAMINER'S OFFICE SENT AN E-MAIL TO REQUEST INFORMATION ON THE COMPOSITION OF THIS PRODUCT. THE INVESTIGATOR REPORTED THAT IT WAS SUSPECTED THAT A CHILD PUT ONE OF THE ENZYMATIC PILLS IN FORMULA HE HAD PREPARED FOR HIS SIBLING IN 2008. THE INVESTIGATOR REPORTED THAT A FEW HOURS LATER, THE PARENTS FOUND THE INFANT UNRESPONSIVE IN BED AND CALLED FOR EMERGENCY ASSISTANCE. THE INFANT WAS PRONOUNCED DEAD ON THE SCENE. THE INVESTIGATOR INDICATED THE INFANT APPEARED TO HAVE BEEN A HEALTHY INFANT OF AVERAGE WEIGHT AND HEIGHT AND NORMAL DEVELOPMENT. PRODUCT INFORMATION INCLUDING COMPOSITION, LABELING AND TOXICOLOGY SAFETY DATA WERE PROVIDED TO THE INVESTIGATOR. THE INVESTIGATOR STATED SHE WILL PROVIDE INFORMATION CONCERNING THE CAUSE OF DEATH WHEN THE INVESTIGATION IS COMPLETED IN 4-6 WEEKS.

    Description of Event or Problem · 1

    THE CHIEF INVESTIGATOR FROM THE MEDICAL EXAMINER'S OFFICE SENT AN E-MAIL TO REQUEST INFORMATION ON THE COMPOSITION OF THIS PRODUCT. THE INVESTIGATOR REPORTED THAT IT WAS SUSPECTED THAT A (B)(6) CHILD PUT ONE OF THE ENZYMATIC PILLS IN FORMULA HE HAD PREPARED FOR HIS (B)(6) SIBLING ON (B)(6) 2008. THE INVESTIGATOR REPORTED THAT A FEW HOURS LATER, THE PARENTS FOUND THE INFANT UNRESPONSIVE IN BED AND CALLED FOR EMERGENCY ASSISTANCE. THE INFANT WAS PRONOUNCED DEAD ON THE SCENE. THE INVESTIGATOR INDICATED THE INFANT APPEARED TO HAVE BEEN A HEALTHY INFANT OF AVERAGE WEIGHT AND HEIGHT AND NORMAL DEVELOPMENT. PRODUCT INFORMATION INCLUDING COMPOSITION, LABELING AND TOXICOLOGY SAFETY DATA WERE PROVIDED TO THE INVESTIGATOR ON (B)(6) 2008 AND (B)(6) 2008. THE INVESTIGATOR STATED SHE WILL PROVIDE INFORMATION CONCERNING THE CAUSE OF DEATH WHEN THE INVESTIGATION IS COMPLETED IN 4-6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE ENZYMATIC CLEANER LENS CARE CLEANERS LPN ALCON - FORT WORTH - ALCON LABORATORIES INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1