Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6107

2. Registrant Information.

Registrant Reference Number: 2014CK404

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.

20-OCT-14

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. Unknown

Product Name: Advantage unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 approximately 2000 a 4 year old, male unknown Breed canine, of unknown signalment and in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage for dogs (imdicloprid).The dog was treated on an unknown basis for several years.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

18

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?

Persisted until death

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 and unknown date in 2014 the dog died. It is unknown if a necropsy was performed.

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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 not expected after product application, as inconsistent with pharmaco-toxicological product profile. Very limited information (product, medical history and chronology) provided and attempts to obtain further specific details have been unsuccessful. It is unknown if a necropsy was performed. Other etiologies are more probable. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. No signs of allergy/anaphylactic reaction reported. Though time to onset unknown, death is inconsistent with the pharmacological product profile and occurred long time after initiation of product use in year 2000. Cause for death probably unrelated to product use but rather associated with dog's high age and underlying health/geriatric conditions. In the end, product involvement was considered unlikely.