Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2266

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0021907 (Report 487168)

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.

17-MAY-18

5. Location of incident.

Country: UNITED STATES

Prov / State: WISCONSIN

6. Date incident was first observed.

02-MAY-18

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 Large Dog

• 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?

Yes

9. Application Rate.

1

Other Units: collar

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

Site: Animal / Usage sur un animal domestique

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

On 30-Apr-2018, a x old, woman, in unknown condition, with concomitant medical conditions of low grade asthma, a history of premature ventricular contraction and fibromyalgia, was exposed to an unknown amount of 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar when she would pet the dog and slept in the same bed as the dog after collar application.

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Fatigue

• Cardiovascular System
  • Symptom - Arrhythmia
  • Symptom - Other
  • Specify - Abnormal ECG
  • Symptom - Other
  • Specify - Premature ventricular contractions

4. How long did the symptoms last?

Unknown / Inconnu

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

No

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)

Contact with treated area

Amount of time between application and contact 48

Hour(s) / Heure(s)

What was the activity? was exposed to an unknown amount of 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar when she would pet the dog and slept in the same bed as the dog after collar application.

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.

>24 hrs <=3 days / >24 h <=3 jours

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 02-May-2018, the individual experienced fatigue and a heart flutter (arrhythmia). The individual was examined by an urgent care physician and an electrocardiogram was performed. The results of the electrocardiogram were abnormal and the woman was referred to the emergency room. The individual was examined by an emergency room physician, bloodwork and another electrocardiogram were performed. The electrocardiogram revealed premature ventricular contractions. No treatments were provided and the individual was sent home. On 14-May-2018, the individual removed the collar from her dog. On 16-May-2018, the individual performed a stress test with pending results. The clinical signs continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N - Unlikely Indirect product exposure occurred as person pet and slept with treated dog in the same bed. Affected site not in line with exposed site. In this case fatigue likely associated with reported arrhythmia. Reported cardio vascular disorders 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. In this case, individual already has concomitant medical condition of premature ventricular contraction and asthma which likely contributed to signs. Time to onset is not consistent. In the end, a product involvement is considered unlikely. Initial assessment/causality confirmed by Medical Doctor.