Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3587

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0042230 (Report 507269)

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.

Domestic Animal

4. Date registrant was first informed of the incident.

27-JUL-18

5. Location of incident.

Country: UNITED STATES

Prov / State: ARKANSAS

6. Date incident was first observed.

26-JUL-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. 11556-155

Product Name: Seresto Cat

• 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 an unknown date in approximately 2018, a 4 year old, feline, whose breed, weight, and condition are unknown, with no known concomitant medical conditions, had 1 Seresto Cat collar (Flumethrin-Imidacloprid) placed around her neck by the owner.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Respiratory System
  • Symptom - Choking

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

26Jul2018, the collar did not break away or ratchet release causing cat to choke and pass away. No known necropsy was performed.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable Choke and death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Death in this case is likely a consequence of reported choke which may have resulted due to possible trapping of animal in collar, although not reported. It was reported that collar did not break away or ratchet release causing cat to choke and pass away. Unknown if collar was trapped to another object or if cat was self trapped. Unknown if cat was just found like this or if anything was observed beforehand. Unknown if collar was fitted correctly. Finally, considering no necropsy result and limited information regarding event leading to the signs, product involvement is deemed to be unassessable.