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: 2019-1875

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0007403 (Report 549796)

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.


5. Location of incident.


Prov / State: OHIO

6. Date incident was first observed.


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.


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

Product Name: Seresto collar Small

  • Active Ingredient(s)
      • Guarantee/concentration 4.5 %
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)


Application Information

8. Product was applied?


9. Application Rate.


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 06-Mar-2019, a 13 year old, 12.7 pound, neutered, female, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, had 1 Seresto Cat (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?


Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms


  • Gastrointestinal System
    • Symptom - Loss of appetite
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Limpness
  • General
    • Symptom - Vocalizing
    • Symptom - Weakness
    • Symptom - Hypothermia
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Fasciculations
  • Cardiovascular System
    • Symptom - Cardiac arrest
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident


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 07Mar2019, the cat refused to eat in the morning (inappetent) and the owner removed the collar. At approximately 3 pm in the afternoon, the cat became limp and began vocalizing. At approximately 4pm the cat presented to the veterinarian. Upon examination, the cat was weak, vocalizing, had a temperature of 98 (hypothermic), and began to seizure. The seizure resolved after approximately 30 seconds, but the cat continued to have focal facial fasciculation. The cat was placed on oxygen. The cat then went into cardiac arrest. Cardio- pulmonary resuscitation was initiated and the cat was administered intracardiac injections of epinephrine and atropine. Cardio-pulmonary resuscitation was unsuccessful and the cat was pronounced dead. No necropsy was performed. The veterinarian suspects that the collar was counterfeit. MAH comment: This collar is suspected to be a counterfeit.

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification


19. Provide supplemental information here

O - Unclassifiable/unassessable This collar is suspected counterfeit product. Nevertheless, even with the genuine collar, the reported signs of innapetance, weakness, vocalization and hypothermia are not expected and may have numerous other causes. Those signs are rather a manifestation of neurological signs reported: limpness, fasciculation, seizures and following sign of cardiac arrest. However, such signs, including serious signs of seizures, cardiac arrest and death are not expected following appropriate product use. The product is not anticipated to cause any serious neurological disorders such as seizures or death after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of adult cats for an 8 months period and in 10 week old kittens for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Time to onset short though. Considering the product profile, product involvement is deemed unlikely, however due to limited information and reported suspected counterfeit the case is considered unassessable.