Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-2989

2. Registrant Information.

Registrant Reference Number: 2014CK211

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.

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 unknown date in 2014, an approximately 1 week old, 4 pound, intact, male, black-tailed cervide, in poor condition with seizures, ataxia and failure to thrive, was administered an unknown amount of Advantage (dog -unspecified) (Imidacloprid) topically by the shelter staff. This is an extra-label use of the product as it is not intended to be used on cervidea.

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

Other / Autre

specify deer

3. Breed

black tailed deer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.02

7. Weight (provide a range if necessary )

4

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

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 an unknown date in 2014, approximately three days after application, the fawn died. The fawn was not examined by a veterinarian and it is unknown if any medical treatments were provided. A necropsy was not 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

Reason for product use unknown. Although application is an off label use reported signs are not expected after topical application as inconsistent with pharmaco-toxicological product profile and experience. No specific data for cervidae available. The product has a wide margin of safety: : the No Effect Level (oral) for Advantage is 645 mg/kg BW and the dermal NOEL 2,000 mg/kg BW . Worst case scenario: deer received Advantage 100 blue = 400 mg Imidacloprid = 89 mg/kg BW topical. Based on the NOEL would not expect any effect of the application. The onset time is not suggestive for an product relation either as too long. The young animal was known with a concomitant medical history of seizures, ataxia and failure to thrive, therefore death more likely related to underlying cause of pre-existing signs. Clinical signs of a neonicotinoid toxicity are usually associated with nicotinic or hepatic effects both not reported. Considering all aspects, a product connection is deemed to be unlikely.