Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2325

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0019768 (Report 484907)

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.

11-MAY-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

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. 11556-155

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 Feb 2018, a 5 month old Airedale Terrier canine, in unknown condition, with a genetic heart defect, had one suspected counterfeit Seresto Large Dog (Flumethrin-Imidacloprid) placed around the neck by the owner. This is a suspect counterfiet collar.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Airedale Terrier

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.41

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

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Other
  • Specify - Congenital cardiovascular disorder NOS

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

On an unknown date in approximately Apr2018, the canine died of a heart defect. A necropsy was conducted. The intent of the initial comunication was to inquire about product use on other pets and not to report this event. Limited details are known and will be reported as such. Follow-up, 17 April 2018: The collar was suspected to be a counterfeit product.

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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 Product was suspected to be counterfeit. However, reported heart defect and subsequent death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, animal involved in this case had concomitant condition of pre existing heart defect which was primary death cause. Additionally, owner does not think about product involvement as intent of the initial communication was to inquire about product use on other pets and not to report this event. Furthermore, time to onset is not suggestive of product relation. Nevertheless, as suspected counterfeit product used, no final conclusion about product causality can be made and product relation is deemed unassessable.