Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5496

2. Registrant Information.

Registrant Reference Number: 2016CK221

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.

06-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-SEP-16

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).

6yr mn schnauzer 12kg was treated with 1 tube of k9 advantix II large on September 6th at 10am.

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

schnauzer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

12

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• Eye
  • Symptom - Nystagmus

• Nervous and Muscular Systems
  • Symptom - Recumbent
  • Symptom - Seizure
  • Symptom - Muscle tremors
  • Symptom - Other
  • Specify - hyperaesthesia on back

• Renal System
  • Symptom - Lack of control of urination
  • Symptom - Other
  • Specify - uroliths

• Eye
  • Symptom - Other
  • Specify - eyes rolling back

• Liver
  • Symptom - Elevated liver enzymes
  • Specify - elevate ALT

12. How long did the symptoms last?

Unknown / Inconnu

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?

2

Day(s) / Jour(s)

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

At 12 noon the dog was found outside and couldn't walk, eyes rolled back. Owner initially believed he had been hit by a car, however, there were no external signs of trauma. The owner also reported that the dog had a seizure. On examination by a veterinarian, the dog was described as being in a stupor, had vertical nystagmus, generalized muscle tremors, hyperaesthesia on the back. The veterinarian bathed the dog and placed him on fluids. The dog did not believe the k9 advantix was responsible for the clinical signs and suspected a systemic toxicity. Blood work was performed. CBC was normal. Biochemistry showed a mild-moderate elevation in ALT. The owner declined a referral for a neuro consult. The dog was hospitalized. The dog started vomiting later that evening. The dog received ampicillin and cerenia. The next day the dog was urinary incontinent. xrays showed bladder stones. The dog was discharged on September 9th with no neurological signs. the owner declined treatment for the bladder stones and urinary incontinence.

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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

The dog was left outside unattended for several hours. A clinical pathologist reviewed the blood work and believed the elevated liver enzymes to be pre-existing. The attending DVM did not believe the clinical neurological signs to be related to the K9 Advantix application. He also believed the uroliths and urinary incontinence to be unrelated to the K9 Advantix application.