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: 2019-2320

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0014291 (Report 556254)

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.

13-APR-19

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

02-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 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 approximately 02-Apr-2019, a 10 year old, 96 pound, neutered, male, Border Collie/Retriever Labrador (No Description) crossbred canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie/Retriever Labrador crossbred canine

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

43.54

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

  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • General
    • Symptom - Weakness
    • Symptom - Death
  • Liver
    • Symptom - Elevated liver enzymes
  • Skin
    • Symptom - Other
    • Specify - Malodour]
    • Symptom - Hair loss
    • Symptom - Irritated skin
    • Symptom - Lesion
    • Symptom - Other
    • Specify - Application site serous discharge
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

Persisted until death

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

Yes

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 10-Apr-2019, the dog exhibited a malodor. The collar was removed and the dog exhibited application site alopecia, application site irritation, an application site lesion and application site serous discharge. On approximately 11-Apr-2019, the dog was examined by a veterinarian. The dog was administered an unspecified antibiotic to be continued orally. Post administration of the antibiotic, the dog developed vomiting, lethargy and anorexia. On 12-Apr-2019, the dog was examined by an emergency veterinarian. Lab work was performed and revealed elevated bilirubin. The dog was administered unspecified anti-emetics and antibiotics at an unspecified duration and route. The dog developed recumbency and weakness. On approximately 14-Apr-2019, the dog died. No necropsy was performed.


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 Malodour is not anticipated with product administration as the collar is odorless. Malodour may have multiple other causes (e.g. diet, fur condition, tartar) and may be rather connected to the pet than the product. It must be considered that odor is subjective to the concerned individual. Moreover, in this case malodour may be associated with application site disorders. Transient mild application site disorders may occur in sensitive animals after product application but the described application site serous discharge is not typically seen with product use. Time to onset is consistent. Further vomiting, lethargy, weakness and anorexia unspecific, however in this case signs may be associated with elevated bilirubin. Later, reported elevated bilirubin, recumbency and 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. However, Signs occurred after collar removal hence a product relation is unlikely. Product has wide margin of safety. Time to onset is long. Other causes must be considered in geriatric dog. Although, no necropsy performed. Product relation for the case is unassessable.