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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3029

2. Registrant Information.

Registrant Reference Number: 2016-107606

Registrant Name (Full Legal Name no abbreviations): Bayer Inc. Consumer Care

Address: 2920 Matheson Blvd East

City: Mississauga

Prov / State: Ontario

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

27-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. N/A

Product Name: Product name unknown

  • Active Ingredient(s)
    • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES (ORTHO & PARA ISOMERS)
      • Unknown

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Death

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Case Description: This case report from UNITED STATES was derived from medical literature on 27-MAY-2016 , article entitled "The toxicity of picaridin containing insect repellent reported to the National Poison Data System.". It refers to a male patient of unspecified age. Trade name of Bayer product was not reported. Case report: This case refers to an adult male patient who had unintentional exposure to DEET (N,N-Diethyl-3-methylbenzamide) anddied. The patient died as a result of the exposure or as a direct complication of the exposure, where the complication was unlikely tohave occurred had the toxic exposure not preceded the complication. Authors comment:In the study one death was identified, an adult male with unintentional exposure to an insect-repellent containing DEET. Publication Abstract:Context: While low toxicity is reported, there are sparse data on the safety of acute picaridin (icaridin) exposures in humans. Objective: The purpose of this study was to review National Poison Data System (NPDS) data regarding ingestion of insect repellents containing picaridin and compare those to insect repellents containing DEET and other insect repellents not containing DEET. Methods: NPDS was queried for single agent human insect repellent ingestions reported between 1 January 2000 and 31 May 2015using the American Association of Poison Control Center generic categories 201048 (Insect Repellents with DEET) and 201049(Insect Repellents without DEET). Picaridin containing product exposures were assessed using PoisindexVR product ID 6744589.Insect repellents of unknown type were not included. Results: 68,429 exposures occurred; 24% were non-DEET-containing products, of which 2% were picaridin- containing products. Among picaridin exposures, 92.9% were managed outside of a health-care facility; there were no reported cases of major effect or death, and only one case of moderate effect. Primary symptoms across all insect repellent exposures included ocular irritation/pain,vomiting, red eye/conjunctivitis, and oral irritation. Treatment primarily included dilution/irrigation/wash. Conclusion: Unintentional ingestion of picaridin-containing and other insect repellents was associated only with minor toxicity and was generally managed outside of a health-care facility. Sender Comments: This case report was derived from medical literature (published report from study) and refers to a male patient of unspecified age who accidentally was exposed to diethyltoluamide and died. DIED, serious due to its fatal outcome, is unlisted in the Reference Safety Information for diethyltoluamide. Cause of death was not provided. In this case, the authors stated that the patient died as a result of the exposure or as a direct complication of the exposure. Considering this information, causality between the reported event and diethyltoluamide cannot be excluded, in a conservative approach.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

Trade name of a Bayer product was not reported