Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-3033

2. Registrant Information.

Registrant Reference Number: 2014CK255

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

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

17-JUL-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

06-APR-14

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. 11556-141

Product Name: K9 Advantix II small 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.

.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 04-Apr-2014, a 10 year old, 8.5 pound, neutered, male, Chihuahua canine, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of K9 Advantix II Small 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

8.5

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Dyspnea

• Cardiovascular System
  • Symptom - Other
  • Specify - unknown cardiac disorder

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?

Unknown

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

On 06 Apr 2014 the dog was breathing heavily and recovered by 07 Apr 2014.On 11 Apr 2014 the dog was breathing heavily again. The patient went to the veterinarian and the radiograph showed an unknown cardiac abnormality. The dog was tread with an unknown injection and the doctor prescribed furosemide.On 12 Apr 2014 the dog died and no necropsy was performed. No more 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

Respiratory distress is not expected after application of Advantix, and likely consequence of the concomitant cardiac disorder. Death is not expected after product application. Time to onset very long, therefore allergic/anaphylactic reaction can be ruled out. Death likely related to the concomitant cardiac status. Considering all aspects, product relation is deemed to be unlikely.