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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4523

2. Registrant Information.

Registrant Reference Number: 2013AM202

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. 11556-152

Product Name: Advantage II Large Cat

  • 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 large cat 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 shorthair

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms


  • General
    • Symptom - Death
  • Cardiovascular System
    • Symptom - Other
    • Specify - hypertrophic cardiomyopathy
  • Liver
    • Symptom -
    • Specify - chronic hepatic congestion
  • Renal System
    • Symptom - Other
    • Specify - chronic renal infarction

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?

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 15May2013, an approximately 2 year old, 11.4 pound, neutered, male, Domestic Shorthair, in fair condition, in fair condition, with a history of longstanding left ventricular with hypertrophy and dysfunction, chronic hepatitis, and chronic renal infarction, was administered one Rabies vaccine, one Distemper vaccine, one tablet of Nitenpyram, and 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) once topically by the attending vet. Approximately 3 hours later, the patient passed away. A necropsy is pending. Update: 2013-06-10. A necropsy was performed that showed the following result, which confirmed the concomitant medical conditions: hypertrophic cardiomyopathy, chronic hepatic congestion, and chronic renal infarction.

To be determined by Registrant

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


19. Provide supplemental information here

ntended direct topical dermal exposure of the product to the cat. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. 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. Other products given concurrently that may have caused signs as well. A necropsy was performed that showed the following result, which confirmed the concomitant medical conditions: hypertrophic cardiomyopathy, chronic hepatic congestion, and chronic renal infarction. Although short onset time, death rather related to cat's underlying serious conditions. Thus, a product relation is considered unlikely.