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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0025

2. Registrant Information.

Registrant Reference Number: 2018EB259

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.

Country: CANADA

Prov / State: QUEBEC

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. 27586      PMRA Submission No.       EPA Registration No.

Product Name: advantage II large cat

  • Active Ingredient(s)

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).

In September 2018, the pet owner applied 1 dose of advantage II large cat topically on a 11 year old 6.4 kg domestic shorthair male neutered cat in good health. (Exact application date unknown). This patient is has a body score of 7/9

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

Medical Professional

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?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms


  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
    • Symptom - Fever
  • Gastrointestinal System
    • Symptom - Stomach pain
  • Liver
    • Symptom - Hyperbilirubinemia
  • Blood
    • Symptom - Hyperglycemia
    • Symptom - Other
    • Specify - hypophosphatemia
    • Symptom - Other
    • Specify - low anion gap
    • Symptom - Other
    • Specify - elevated creatine kinase
  • Gastrointestinal System
    • Symptom - Other
    • Specify - inflammation
  • General
    • Symptom - Other
    • Specify - enlarged lymph nodes
  • Gastrointestinal System
    • Symptom - Diarrhea

12. How long did the symptoms last?

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

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

The patient was seen in clinic on September 17th for vomiting, anorexia and lethargy. The patient had a temperature of 40.5 Celsius on physical exam. Abdominal palpation was tense and painful in the cranial abdomen. Patient was offered canned food that he ate with good appetite. Bloodwork was done and revealed hyperbilirubinemia, mildly elevated glucose, low phosphorus, low anion gap, slightly elevated Creatinine kinase. The patient was treated with SQ fluids, and famotidine. The patient was treated with SQ fluids on September 19th. The patient was hospitalized on September 20th and the patient was treated with IV fluids, pericatin, prednisone, Cerenia and clavaseptin. The patient recovered. An abdominal ultrasound was performed which revealed inflammation of the gastrointestinal tract from the stomach to the colon, mesenteric lymph nodes were very enlarged, presence of a large amount of fluid in the colon consistent with diarrhea. Differential diagnosis includes pancreatitis or gastro-enteritis. The patient was discharged on September 24th and recovered. In November 2018, the pet owner reapplied 1 vial of Advantage Large cat topically on the patient. (Exact application date unknown) On November 20th, the cat had soft stool and vomiting. The patient was treated with probiotics and gastro canned food. The outcome is unknown.

To be determined by Registrant

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


19. Provide supplemental information here