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: 2017-4014

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0019841

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

Address: 2920 Matheson Blvd

City: Mississaugua

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.

30-JUN-17

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar Small cat

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

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).

1 Seresto Cat Collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner.

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

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

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

  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Respiratory distress
  • General
    • Symptom - Other
    • Specify - Unable to rise

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

In approximately 2016, a 10 year old, female cat of unknown signalment and condition, with concomitant medical conditions of fleas and anemia, had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. At an unspecified time post application in 2016 the cat was administered an unspecified dose of morphine by the owners sister in an attempt to euthanize the cat. The cat developed respiratory distress and was unable to rise. At an unspecified time in 2017 the cat passed away No more information is expected. This case is closed. Follow up received on 1st May 2017: No known necropsy was performed. No more information is expected. This case is closed.


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 respiratory and systemic disorders are not expected with appropriate topical product application. Morphine was administered concomitantly in an attempt to euthanize the animal. Reported respiratory and systemic disorders are likely consequence of morphine administration. Death is not expected following appropriate topical product application as inconsistent with products 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 for an 8 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Concomitant condition of anemia may have contributed to fatal outcome in this advanced aged feline. Finally, even though some information is missing (exact time to onset), considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.