Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0024

2. Registrant Information.

Registrant Reference Number: 2018EB258

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.

19-NOV-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

11-NOV-18

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 November 11 2018, the pet owner applied 1 vial of K9 Advantix II large dog to a Female 5 year old 10.43kg schnauzer of unknown health.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Schnauzer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

10.43

kg

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Vomiting
  • Symptom - Stomach pain
  • Symptom - Bloody vomit

• Blood
  • Symptom - Anemia
  • Symptom - Other
  • Specify - elevated urea

• Renal System
  • Symptom - Creatinine increased
  • Specify - elevated creatinine

• Blood
  • Symptom - Other
  • Specify - elevated creatine kinases

• Liver
  • Symptom - Elevated liver enzymes

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.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

15. Outcome of the incident

Euthanised / Euthanasie

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 November 11th, the patient was lethargic. On November 12, the patient showed abdominal discomfort, anorexia and vomiting. The patient was seen in clinic on November 15th. The patient ate some canned food that was offered to him so the pet owner elected not to have the pet examined. Later that evening the patient vomited the canned food and traces of blood were present in the vomit. November 16th, the patient was evaluated by a veterinarian, bloodwork was done. A Snap 4dx and urinalysis were performed and were normal. The patient was treated with Cerenia, tramadol, famotidine and owner decided to take the patient home. The bloodwork results revealed high urea/creatinine (698), slight anemia (34%), low platelets (69), high creatinine kinase, High AST (132). The patient returned to the veterinary clinic that evening and was hospitalized with gabapentin, IV fluids, ampicillin, sucralfate. The patient still had some intense abdominal pain. November 17th, despite hospitalization and treatments, the patient was not improving. The owners decided to euthanize the patient.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here