Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4090

2. Registrant Information.

Registrant Reference Number: 2015KP117

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Blvd. East

City: Toronto

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.

20-JUL-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-SEP-10

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.       PMRA Submission No.       EPA Registration No. 11556-143

Product Name: k9 advantix II large dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

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).

On 01-Sep-2010, an 11 year old, 26 pound, neutered, male, Boston Terrier canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) topically by the owner.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Boston Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

26

lbs

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Pruritus

• Cardiovascular System
  • Symptom - Other
  • Specify - Heart Failure

12. How long did the symptoms last?

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

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

Died

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

Twelve hours post application, the dog developed pruritus. On 03-Sep-2010 the dog recovered. On approximately 15-Sep-2010, the dog was diagnosed with congestive heart failure. On 18-May-2011, the dog died. No known necropsy was performed. No further information is expected. This case is closed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Though first course of non-serious signs (pruritus) occurred shortly after application, congestive heart failure was diagnosed 2 weeks after application and is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Death occurred 8 months later and was likely consequence of underlying condition of heart failure. Necropsy was not performed. Though consistent time to onset for initial signs, considering all aspects, product connection is deemed to be unlikely.