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: 2020-1507

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0045563

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.

06-AUG-19

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-APR-19

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 Large dog

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • 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).

On an unknown date in Aug 2019,a 10 year old, 81 pound,neutered, female, Boxer canine, in unknown condition, with no known concomitant medical conditions, had one Seresto(imidacloprid and Flumethrin) Large dog collar 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Boxer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

36.8

kg

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

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 approximately 01-Apr-2019 was administered 1 tube of Advantage Multi for Dogs (10% imidacloprid + 2.5% moxidectin) Topical Solution (Imidacloprid and Moxidectin) 4.0mL topically by the owner. On approximately 15-Apr-2019, the dog exhibited a nonspecific behavioral change, agitation, dyspnea and coughing. On approximately 01-May-2019, the dog was evaluated by a veterinarian then referred to a cardiologist. Unspecifieddiagnostics revealed congestive heart failure. The dog was administered a regimen of unspecified cardiac medications orally. The dog again was administered 1 tube of Advantage Multi for Dogs (10% imidacloprid + 2.5% moxidectin) Topical Solution (Imidacloprid and Moxidectin) 4.0 mL topically by the owner. On approximately 10-May-2019, the behavioral change, agitation, dyspnea and coughing resolved.On approximately 01-Jun-2019 the dog was administered 1 tube of Advantage Multi for Dogs (10% imidacloprid + 2.5% moxidectin) Topical Solution (Imidacloprid and Moxidectin) 4.0mL topically by the owner. On approximately 09-Jul-2019, the dog exhibited pruritus and fleas were visualized. On approximately 21-Jul-2019, the dog was administered 1 tube of Advantage Multi for Dogs (10% imidacloprid + 2.5% moxidectin) Topical Solution (Imidacloprid and Moxidectin) 4.0mL topically by the owner. On approximately 03-Aug-2019, the dog exhibited aural discharge and aural pruritus.On 05-Aug-2019, the dog was evaluated by a veterinarian and diagnosed with otitis. The clinical signs continued. Follow up received on 09-Sep-2019: On an unknown date in Aug2019, the canine had one Seresto (imidacloprid and Flumethrin) Large dog collar placed around the neck by the owner. On 30Aug2019, the canine died. No 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