Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8017

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0074449 (Report 460086)

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.

20-NOV-17

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

01-NOV-17

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556155

Product Name: Seresto Large Dog

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

7. b) Type of formulation.

Tablet

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 approximately 01-Nov-2017, a 17 year old, 40 pound, male, Spaniel (Cocker) canine, in unknown condition, with concomitant medical conditions of blindness, deafness and fleas, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

English Cocker Spaniel

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

17

7. Weight (provide a range if necessary )

18.144

kg

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

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 approximately 01-Nov-2017, a 17 year old, 40 pound, male, Spaniel (Cocker) canine, in unknown condition, with concomitant medical conditions of blindness, deafness and fleas, was administered 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner. On 13-Nov-2017 the canine passed away. No necropsy was performed. No further information s expected. Case is closed. Note: The intent of the call was not to report this event but to inquire about about another dog.


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 death is 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. Other unrelated causes are more probable in this geriatric dog. Moreover, the intent of the call was not to report this event but to inquire about another dog. Time to onset is not suggestive of product relation. Even though no necropsy was performed sufficient information exists to rule out product relation completely. Overall, a product relation is consider as unlikely.