Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6071

2. Registrant Information.

Registrant Reference Number: 2018CK096

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.

26-JUL-18

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII medium 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.

1

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).

A 9yr 6.1kg fs crossbreed dog with a history of bladder stones recently presented to a veterinary clinic for an annual wellness exam. The pet owner was concerned that use of K9 Advantix II in 2017 and 2018 may have contributed to the symptoms.

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

cROSSBRED

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

6.1

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Renal System
  • Symptom - Polyuria

• General
  • Symptom - Polydipsia

• Nervous and Muscular Systems
  • Symptom - Seizure

• Eye
  • Symptom - Blindness (temporary)

• Nervous and Muscular Systems
  • Symptom - Slight paralysis

• General
  • Symptom - Other
  • Specify - Unable to Jump

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?

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

A 9yr 6.1kg fs crossbreed dog with a history of bladder stones recently presented to a veterinary clinic for an annual wellness exam at which time the pet owner reported the dog had polydipsia/polyuria, potential blindness, mobility issues (cannot jump onto bed). The dog also recently presented to a veterinary emergency clinic for an episode of right sided paralysis which the pet owner believes was a seizure. The pet owner was concerned that use of K9 Advantix II in 2017 and 2018 may have contributed to the symptoms. The attending veterinary performed bloodwork which was within normal limits. The veterinarian does not believe the symptoms are attributable to use of K9 Advantix II.

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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

O - Unclassifiable/unassessable Reported polyuria is not expected after topical application of the product. However it along with polydipsia may be associated to concomitant condition of bladder stones. Right sided paralysis, blindness and mobility issues are not anticipated with appropriate topical product administration as inconsistent with pharmaco-toxicological product profile. Other causes should be considered. It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. Seizures more likely coincidental occurrence or dog may have predisposition for idiopathic seizures. Considering unknown time to onset, a product connection is unassessable.