Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3168

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0026719 (Report 568126)

Registrant Name (Full Legal Name no abbreviations): Bayer INC

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

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.

30-MAY-19

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-137

Product Name: Quickbayt Fly Bait

• Active Ingredient(s)
  • (Z)-9-TRICOSENE
    • Guarantee/concentration .1 %
  • IMIDACLOPRID
    • Guarantee/concentration .5 %

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7. b) Type of formulation.

Bait

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Res. - In Home / Rés. - à l'int. maison

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

On an unspecified date in approximately May 2018, a (age) year old, woman, in unknown condition, with concomitant medical conditions of an allergy to cats and an allergy to dust mites, was secondarily exposed to an unknown amount of QuickBayt Fly Bait (unspecified) (cis-9-tricosene and imidacloprid (Muscalure)) on the hands when she scattered the product indoors as needed until approximately May 2018.

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.

Other

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Difficulty swallowing

• Skin
  • Symptom - Hair loss

• Gastrointestinal System
  • Symptom - Weight loss

• General
  • Symptom - Fatigue

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• General
  • Symptom - Other
  • Specify - Other abnormal test result NOS

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?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

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

Other

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.

Skin

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.)

On an unspecified date post exposure, in approximately May 2018, the individual experienced facial tremors, difficulty swallowing, alopecia, weight loss and fatigue.On an unspecified date post onset, in approximately 2019, she was examined by a physician and unspecified diagnostics were performed.On an unspecified date in approximately May 2019, the individual was examined by a physician and a test for toxins was performed that revealed copper was elevated to a toxic level. It was unknown if treatments were performed and the clinical signs continued.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

N - Unlikely On an unspecified date in approximately MAY 2019, a (age) year old woman, in unknown condition was secondarily exposed to an unknown amount of QuickBayt Fly Bait when she scattered the product indoors. After an unspecified time period she experienced facial tremors, difficulty swallowing, alopecia, weight loss and fatigue. On an unspecified date in approximately May 2019, the individual was examined by a physician and a test for toxins was performed that revealed copper was elevated to a toxic level. Reported clinical signs are not expected after exposure to QuickBayt Fly Bait as inconsistent with the toxicological product profile. Although time to onset and timeline unknown based on clinical signs copper poisoning is more likely. A connection with the product can be excluded. (N)This is a preliminary assessment, pending the final assessment after evaluation by medical doctor. If assessment is changed, the final statement will be submitted.