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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0586

2. Registrant Information.

Registrant Reference Number: 2017KP088

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 - 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 08Nov2016, a 1 year old, approximately 40 pound,female, Crossbred canine, of unknown reproductive status and condition, with no known concomitant medical conditions,was administered an unknown dose of afoxolaner by mouth and a rabies vaccine.

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

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

11. List all symptoms


  • General
    • Symptom - Death
    • Symptom - Hyperactivity
    • Symptom - Abnormal behaviour
  • Eye
    • Symptom - Blindness (permanent)
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Shaking
    • Symptom - Recumbent

12. How long did the symptoms last?

Unknown / Inconnu

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?


Day(s) / Jour(s)

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 approximately 13Nov2016, the canine ingested an unknown amount of 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar that was worn by another dog. On 15Nov2016, the canine exhibited hyperactivity and rolling behavior. She was examined by a veterinarian and was blind, hypersalivating, had muscle tremors, shaking and was laterally recumbent. Unknown treatments were instituted and the canine was hospitalized for continued care. On 15Nov2016, while hospitalized, the canine died. It was unknown if a necropsy was performed. No further information expected. Case closed.

To be determined by Registrant

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


19. Provide supplemental information here

Dog ingested another dog's collar. Reported behavioural signs are unspecific and may have numerous other causes. Hypersalivation is unspecific sign, however may be associated with the oral ingestion of the product. Muscle tremor is not expected with appropriate topical product use. Oral product exposure may cause transient gastrointestinal sign but neurological disorder is not typically seen. Shaking is not expected after product application, however, may be associated with muscle tremor. Blindness, lateral recumbency and death are not 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. Time to onset is long. Considering the product profile a connection is considered unlikely, however, as no necropsy performed to reveal other cause, product involvement is considered unassessable.