Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3667

2. Registrant Information.

Registrant Reference Number: 2018CK031

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.

08-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

20-APR-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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII extra 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.

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 17-Apr-2018, a 4 year old, 55 pound, neutered, male, Poodle - Standard dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner.

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

Standard Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

24.94

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• Skin
  • Symptom - Discolouration
  • Specify - hair coat discolouration
  • Symptom - Hair loss

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

This product is not labeled for application on dogs that weigh less than 55.1 pounds and is an off-label over dose of the product. On 20-Apr-2018, the dog developed application site hair coat discoloration and application site alopecia. On 27-Apr-2018, the dog was bathed with a an unspecified dog shampoo. The dog was not evaluated by a veterinarian and the clinical signs continued.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

B - Possible Reported application site hair alopecia most likely reflect local dermal sensitivity to the product. Hair coat discoloration is not expected when product applied as recommended. But in individual cases it may be possible for the product to cause colour transfer from certain materials when in contact with wet product on pet. Considering consistent time to onset and application site involvement, a product connection is deemed to be possible.