Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3836

2. Registrant Information.

Registrant Reference Number: 2015KP190

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

Address: 2920 Matheson Boulevard

City: Missisaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

20-JUN-14

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 Collar - Large Dog

• Active Ingredient(s)
  • Flumethrin
  • 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 10-Jun-2014, a 6 year old, 53 pound, neutered, female, Siberian Husky canine, in fair condition that was recently adopted from a shelter, presented to the veterinarian for an examination. The dog was heartworm positive on a antigen test, was administered an oral ivermectin heartworm preventative, vaccinated for rabies, lyme, leptospirosis, distemper, hepatitis, leptospirosis, parovirus and parainfluenza. The dog had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the attending vet and was started on a daily regime of doxycycline.

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

Dog / Chien

3. Breed

Siberian Husky

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

53

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Unconsciousness
  • Specify - Loss of consciousness

12. How long did the symptoms last?

Unknown / Inconnu

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 20-Jun-2014, the dog vocalized, collapsed and died. The dog was not examined by a veterinarian and no necropsy was performed. No further medical information is expected. The case is closed.

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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

N - Unlikely. Reported signs of vocalization, collapsing and death 10 days after collar application are not expected with appropriate topical product use. Collar was tolerated for 10 days without any signs. Long time to onset is not suggestive of product involvement. Both death and collapse are inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause death 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. The dog has an unknown medical history as it was recently adopted from an animal shelter. The dog was heartworm positive and was started on a treatment regime of doxycyline and an oral heartworm medication. The clinical signs reported are more likely related to the concomitant medical condition or the medications administered. No necropsy was performed. Considering the provided data, sufficient information exists to confirm that the product did not cause the event and product involvement was ruled out. Finally, product relation considered unlikely.