Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-2811

2. Registrant Information.

Registrant Reference Number: 36210

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.

07-JUN-21

5. Location of incident.

Country: CANADA

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. 29779      PMRA Submission No.       EPA Registration No.

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.

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 6-May-2021, a 1 year old, 36.4 kg, male neutered Golden Retriever in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 4.0 ML EX LGE DOG, (-), orally by Animal owner. The product was used according to label (No- inappropriate route)

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Golden retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

36.4

kg

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Abnormal gait

• General
  • Symptom - Pain

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Abnormal behaviour
  • Symptom - Hesitancy to move
  • Symptom - Other
  • Specify - Movement disorder

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

After application the dog became lethargic. On 8 May 2021 the pet owner administerd a dose of Strongid to the dog. On 9 May 2021 the pet owner administered another dose of K9 Advantix II Extra large to the dog topically. After application the dog experienced a movement disorder and appeared to be in pain, was walking abnormally, was hesitant to get in and out of the car, experienced seizure activity, and was not normal. On an unknown date the dog was seen by the attending veterinarian and was prescribed Metacam (meloxicam) and Robaxacet. The medications were not administered, Several weeks later the dog was seen at an emergency clinic for an MRI and spinal tap procedure as the dog was suspected of having meningitis. The outcome is unknown.

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To be determined by Registrant

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

Major

19. Provide supplemental information here