Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0712

2. Registrant Information.

Registrant Reference Number: 2015KP347

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.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

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.       PMRA Submission No.       EPA Registration No. 11556-135

Product Name: k9 advantix 55

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

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7. b) Type of formulation.

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 an unspecified date in Apr- 2013, a 17 year old,neutered, male, German Shepherd Dog/Alaskan Malamute/Wolf Hybrid crossbred canine, of unknown weight and condition, with no known concomitant medical conditions,was administered 1 tube of K9 Advantix 55 (Imidacloprid -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

German Shepherd/Alaskan Malamute/Wolf Hydrid

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

17

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

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

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 an unspecified date, in Jun 2013, the dog died. It is unknown if a necropsy was performed. The caller contacted Bayer Animal Health to inquire about product use on other dogs and not to report the death of this dog. No further information is expected 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

Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. Time to onset of about 2 month much too long. Other causes are more probable. e.g. old age. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time (2 years) after. Moreover, the reason for the initial call was to discuss about product use on other dogs and not to report the death of this dog. Finally, even though some information missing (no necropsy, animal data), based on chronology a product relation is deemed to be unlikely.