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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0445

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0076461 (Report 462407)

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.


5. Location of incident.



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 Large Dog

  • Active Ingredient(s)
      • 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 12-Nov-2017, a 3 year old, approximately 95 pound, neutered, male, Shepherd Dog - German dog, in unknown condition, with a history of having had one seizure, had 1 collar of Seresto Large Dog (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?


Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd Dog

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?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms


  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Collapse
  • Gastrointestinal System
    • Symptom - Drooling
  • Skin
    • Symptom - Rash

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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 15Nov2017, the dog developed a rash on his ears, chest, abdomen and groin and he developed a seizure NOS and Seresto was immediately removed and the dog was bathed with an unspecified shampoo. On an undetermined date post product removal, the Seresto collar was placed on the table and it sat for two days and the finish was eaten away where the Seresto collar had been sitting. The dog had not been evaluated by a veterinarian. On 29Nov2017, the dog developed a seizure NOS, was lethargic and drooling. Approximately 10 minutes post clinical sign onset, the dog appeared to be improving and was taken outside for some fresh air. Approximately 20 minutes post clinical sign onset, the dog was acting happy and was running outside and he collapsed and died in front of the animal owner. The dog had not been evaluated by a veterinarian. No necropsy was performed.

To be determined by Registrant

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


19. Provide supplemental information here

O- Unassessable: Reported rash on other than the application site is not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorder is not expected. The product is not anticipated to cause serious neurological disorder such as seizure after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizure was reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies 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. Even with oral product exposure (unknown if occurred), seizure is not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. As pet showed seizure prior to product use, seizure was likely related to this underlying condition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Drooling and lethargy are unspecific and may be associated with the later reported seizures. Reported serious signs such as collapse and death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Moreover, later reported signs observed after collar removal, hence not product related. Though time to onset is consistent for reported rash, it is long for other reported signs. Considering all aspects, a product involvement is unassessable. Clinical signs of sudden death, as observed in this case, usually indicate a heart abnormality. The collar was removed 13 days prior, so no active ingredient would be expected to be present. No necropsy was performed, so cause of death can not be determined.