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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4279

2. Registrant Information.

Registrant Reference Number: 2016KP159

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: UNKNOWN

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 - Dog

  • Active Ingredient(s)
    • Flumethrin
      • 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 10-Jun-2016, a 3 year old, 140 pound, neutered, female, Newfoundland 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?


Subform III: Domestic Animal Incident Report

1. Source of Report


2. Type of animal affected

Dog / Chien

3. Breed


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?

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

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms


  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Disorientation
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
    • Symptom - Polydipsia
  • Gastrointestinal System
    • Symptom - Retching
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Eye
    • Symptom - Other
    • Specify - Periorbital oedema
  • Gastrointestinal System
    • Symptom - Vomiting

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 17-Jun-2016, the dog exhibited disorientation and the behavior changes of sleeping in a different room, standing in the middle of the street and not coming when her name was called. On 18-Jun-2016, the dog exhibited retching, inappetence and an unspecified eye was swollen. The dog was examined by a veterinarian and no treatments were performed. On 19-Jun-2016, the dog exhibited lethargy, polydipsia and anorexia. The dog was not re-examined by a veterinarian and the signs continued. Follow up received on 28 Jun 2016: On 17-Jun-2016, the dog exhibited disorientation, lethargy, ataxia and the behavior changes. The dog was examined by a veterinarian and no treatments were performed. On 18-Jun-2016, the dog exhibited vomiting, retching, inappetence and periocular edema. The dog was re-examined by a veterinarian and no treatments were performed. Physical exam was noted to be within normal limits. On 19-Jun-2016, the dog exhibited polydipsia and diarrhea. The dog was examined by a veterinarian who performed unspecified blood work and a radiograph; the results were within normal limits. On 20-Jun-2016, the dog received unspecified fluids via an unspecified route by the veterinarian. On 21-Jun-2016, the veterinarian repeated an unspecified blood work panel and radiograph. The results were within normal limits. The dog died. No known necropsy was performed.

To be determined by Registrant

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


19. Provide supplemental information here

Reported behavioural disorders and lethargy are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Ataxia is not anticipated with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs but no neurological signs would be expected. Reported digestive disorders are also unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Periocular oedema is not expected after product application as sign is not in line with pharmaco toxicological product profile. Death is also not expected after 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 and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. Animal health status and medical history is unknown. Even though time to onset is consistent for initially reported signs, considering long time to onset for later observed signs and death and taking into consideration the known product profile a product relation is unassessable.