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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4578

2. Registrant Information.

Registrant Reference Number: 2013AM195

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. 11556-130

Product Name: Advantage II Extra Large Dog

  • Active Ingredient(s)
      • Guarantee/concentration 8.8 %
      • 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 Advantage II extra 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

Cat / Chat

3. Breed

Domestic short hair

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms


  • General
    • Symptom - Death
  • Cardiovascular System
    • Symptom - Other
    • Specify - enlarged heart
  • Respiratory System
    • Symptom - Other
    • Specify - fluid filled lungs
  • Liver
    • Symptom - Other
    • Specify - blood clots around the liver
  • General
    • Symptom - Other
    • Specify - hypertrophy on left side
  • Respiratory System
    • Symptom - Other
    • Specify - abundance of foam in the trachea

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 26Apr2013, a 12 year old, 13 pound, spayed, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered an unknown amount of Advantage II Extra Large Dog (Imidacloprid- Pyriproxyfen) once topically by the owner. This is an off label usage of the product; the product is not intended for use on cats. The patient is an outdoor cat. The morning of 29Apr2013 the patient was found deceased. The attending veterinarian performed a gross necropsy and the patient was noted to have an enlarged heart, and fluid filled lungs, blood clots around the liver, hypertrophy on the left side and an abundance of foam in the trachea.

To be determined by Registrant

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


19. Provide supplemental information here

Intended misused direct topical dermal exposure of the product to the cat. Exposed site is inconsistent with affected site. Sudden death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Time to onset (3 days) too long. Product has wide margin of safety. Oral LD50 in rat 642 mg / kg BW. 24-fold overdosage tolerated by cats without showing any side effect. No signs of allergy or anaphylaxis reported. Other causes more likely. Necropsy revealed underlying heart disease. Considering this, a product relation is considered unlikely.