Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0232

2. Registrant Information.

Registrant Reference Number: 2017BS065

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-JAN-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-DEC-15

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: k9 advantix II 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).

Dog 1: On 12-Aug-2017, a 1.5 year old, 11 pound, intact, female, Shih Tzu/Poodle (Miniature) crossbred canine, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of non-US Registered Product, K9 Advantix II Medium (Imidacloprid-Pyriproxyfen-Permethrin) topically by the owner. Dog 2: On 12-Aug-2017, a 4.5 year old, 9 pound, intact, female, Shih Tzu/Poodle (Miniature) crossbred canine, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of non-US Registered Product, K9 Advantix II (unspecified) (Imidacloprid-Pyriproxyfen-Permethrin) topically by the owner.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

shih tzu x poodle

4. Number of animals affected

2

5. Sex

Female

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

4.99

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Pruritus
  • Symptom - Rash

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.

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

On 13Aug2017 the dog developed application site pruritus and application site rash. On 16Aug2017 the dog was bathed with an unspecified shampoo. The dog was not examined 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

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Shih tzu x poodle

4. Number of animals affected

2

5. Sex

Female

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

4.1

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Pruritus
  • Symptom - Rash

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

On 14Aug2017 the dog developed application site pruritus and application site rash. On 16Aug2017 the dog was bathed with an unspecified shampoo. The dog was not examined 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

Moderate

19. Provide supplemental information here