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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3047

2. Registrant Information.

Registrant Reference Number: 2013AM117

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

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. 11556-144

Product Name: K9 Advantix II Large dog

  • Active Ingredient(s)
      • Guarantee/concentration 8.8 %
      • Guarantee/concentration 44 %
      • Guarantee/concentration .44 %

7. b) Type of formulation.


Application Information

8. Product was applied?


9. Application Rate.


Units: mL

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).

One vial of K9 Advantix II Large dog was applied topically by the owner to one spot on the dorsal midline.

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

French Bulldog

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


  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Weakness
    • Specify - weak
  • Eye
    • Symptom - Pupil dilation
  • General
    • Symptom - Abnormal behaviour
    • Specify - circling
  • Nervous and Muscular Systems
    • Symptom - Seizure

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?


Hour(s) / Heure(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 07-Jan-2013, the patient began vomiting, having diarrhea, was weak, had dilated pupils, and was circling. On 08-Jan-2013, the owner bathed the patient with a baby shampoo. The dog was taken to the veterinary clinic where they performed an examination and administered atropine sulfate. Follow up of 21-Jan-2013: The dog was hospitalized overnight and IV fluids (unspecified) was given. On 09 Jan 2013 the owner declined treatments and diagnostics suggested by the DVM due to financial concerns and the dog was taken home by the owner. On the same day the dog had seizures and died of unknown causes. 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

Digestive tract disorders rather unspecific in dogs and may have multiple various other causes, and not expected following topical application of product. Potential oral ingestion not reported. Although sign rather unspecific, lethargy may exceptionally occur in particular sensitive dogs or may be consequence of digestive tract disorders. Even though more expected after oral ingestion, Permethrin has potential to cause slight neurological disorders (e.g. ataxia) in particular susceptible animals. Dilated pupils not expected following appropriate product application. Known that none of active ingredients in product has potential to provoke seizures in dogs, neither alone nor in combination. Seizures reported by owner and no vet consulted. Thus possibly misinterpretation of sign. Death not expected in dog after product application, as inconsistent with pharmacotoxicological product profile. Low level of information (necropsy not available). Considering breed of dog, other etiologies more probable. No signs of allergy/anaphylactic reaction reported. Onset time of digestive disorders, lethargy, dilated pupils, and circling consistent, time to onset of seizure and death long. Considering all aspects, product connection deemed to be unlikely.