Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-1758

2. Registrant Information.

Registrant Reference Number: 2014CK107

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.

17-APR-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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.

Active(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-144

Product Name: K9 Advantix II (extra large dog)

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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).

On 03-Mar-2014, a 7 year old, 65 pound, intact, female, Crossbred canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) once topically by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

65

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite

• Respiratory System
  • Symptom - Panting

• Nervous and Muscular Systems
  • Symptom - Difficulty getting up

• Respiratory System
  • Symptom - Coughing

• General
  • Symptom - Parasitism
  • Specify - heartworm

• Gastrointestinal System
  • Symptom - Other
  • Specify - hemothorax
  • Symptom - Other
  • Specify - hemoperiteneum

• Respiratory System
  • Symptom - Nose bleed
  • Specify - serosanguineous fluid oozing from nostrils

• Gastrointestinal System
  • Symptom - Abdominal distension
  • Specify - stomach enlarged and destended by gas
  • Symptom - Other
  • Specify - hemorrhages (gastric serosa diffusely red)
  • Symptom - Other
  • Specify - gastric mucosa diffusely edematous

• Blood
  • Symptom - Other
  • Specify - spleen had raised nodules (1-2.5cm diameter)

• Respiratory System
  • Symptom - Other
  • Specify - lungs diffusely mottled pale and red, oozing blood on cut surface
  • Symptom - Other
  • Specify - distal trachea contains abundant blood

12. How long did the symptoms last?

Persisted until death

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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

Approximately 4 hours post application, the dog was inappetent.On 04Mar2014, the dog was less active.On 05Mar2014, the dog was unable to rise, panting and coughing. Then the dog collapsed and died. Follow-up 12 March2014. On 06Mar2014 the dog's remains were taken to the veterinarian and then transported to the University for necropsy. On 07Mar2014 necropsy performed at the University of (name). On 12Mar2014 the preliminary pathology report was hemothorax and hemoperiteneum and heartworms present in the heart. On 17Mar2014 final pathology report. A moderate amount of serosanguineous fluid oozes from both nostrils. The stomach was massively enlarged and destended by gas and the gastric serosa is diffusely red due to congestion and hemorrhages. The gastric mucosa is diffusely edematous. The spleen had slightly raised nodules ranging from 1 to 2.5 cm in diameter. The thoracic cavity contained 50 ml of dark red fluid. The lungs are diffusely mottled pale and red and ooze blood on cut surface. The distal trachea contains aboundent blood. The pericardium contained 5 ml of dark red fluid. Eleven long white nematodes (consistent with Dirofilaria immitis) are present in the right ventrical and pulmonary artery. No significant gross findings are noted within other organs. Diagnoses: severe, diffuse, acute, gastric dilation with congestion and hemorrhage; moderate to severe acute, diffuse, pulmonary edema and congestion; right ventricular and pulmonary arterial heartworms.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Inappetence is a rather unspecific sign, however could be a behavioural response to the discomfort caused by theapplied product. Although sign is rather unspecific, lethargy may exceptionally occur in particular sensitive dogs. Time to onset is consistent for both signs. Inappetence is a rather unspecific sign, however could be a behavioural response to the discomfort caused by theapplied product. Although sign is rather unspecific, lethargy may exceptionally occur in particular sensitive dogs. Time to onset is consistent for both signs. Unable to rise (recumbency), panting, cough, collapse, gastric dilation, haemothorax, peritoneal haemorrhage and death are not expected and not consistent with product's pharmacotoxicological profile. A necropsy was carried out to investigate the cause. Diagnoses according to the necropsy report was severe, diffuse, acute, gastric dilation with congestion and hemorrhage; moderate to severe acute, diffuse, pulmonary edema and congestion; right ventricular and pulmonary arterial heartworms. Time to onset considered too long for all serious signs. Finally, considering all aspects, a product connection is deemed unlikely.