Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3617

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0034881 (Report 576412)

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

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

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

Human

4. Date registrant was first informed of the incident.

26-JUN-19

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

15-FEB-19

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. 11556155

Product Name: Seresto Collar unknown

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

No

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.

Data Subject

2. Demographic information of data subject

Sex: Male

Age: >6 <=12 yrs / > 6 < = 12 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Mental impairment NOS

4. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

Unknown

6. a) Was the person hospitalized?

Yes

6. b) For how long?

4

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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.)

On approximately, 15-Feb-2019, the boy experienced intermittent grand mal seizures, 1 episode of emesis that resolved approximately 5 minutes post onset and mental impairment. A toxicology blood screening panel and other unspecified blood panel were performed and were both within normal limits. The boy continued to have intermittent seizures and was examined by a pediatrician on emergency. Magnetic Resonance Imaging testing was performed of the brain with the results within normal limits. Approximately 12 hours post onset, the boy recovered. It was unknown if treatments were performed. The boy remained hospitalized for observation.On 19-Feb-2019, the boy was released from the hospital.On 26-Jun-2019, the boy had a follow up exam performed with a pediatric neurologist, anThis morning her son had an appointment with a pediatric neurologist. An electroencephalogram was performed and showed normal brain activity.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N - Unlikely An individual was secondarily exposed to collar, when dog slept in the bed with the boy. Affected site is not in line with exposed site. Reported serious neurological signs are not expected with appropriate product use as not consistent with product's pharmacological profile. The collar is odorless and its active ingredients not volatile at room temperature. Other causes are more likely in individual with concomitant history of digestive tract disorders and elevated blood pressure. Further, emesis is not expected after product exposure, however in this case it may be a consequence of reported seizures. Though, time to onset is short. Considering, no oral exposure and known safety profile of the product and available information, an overall product involvement is unlikely.Preliminary assessment. Pending the final assessment after evaluation by medical doctor. If assessment is changed, the final statement will be submitted.