Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0405

2. Registrant Information.

Registrant Reference Number: 2014CK030

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.

16-JAN-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-AUG-13

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. 11556-127

Product Name: Advantage II large dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • 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 an unknown date in August 2012, a 10.5 year old, male, Retriever Labrador (No Description) canine, in fair condition, with history of seizures controlled with an unknown seizure medication, was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) once 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10.5

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

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Weight loss

• Eye
  • Symptom - Blindness (permanent)

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 approximately 15-Aug-2013 the dog exhibited seizures that became progressively worse. The dog later developed ataxia, weight loss, and blindness. On 05-Sep-2013 the dog passed away. No treatments or diagnostics were performed. No necropsy was performed.The owner initially contacted Bayer Animal Health to seek advise on application of the product and not to report the death of this pet.

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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

The information regarding the death of the dog was casually provided during an inquiry. Seizures resulting in reported signs and eventually death are not anticipated with topical administration of Advantage II. From a toxicological point of view, imidacloprid or pyriproxyfen do not have the potential to provoke seizures in vertebrates. Time to onset of death after last exposure with more than one year. Medical history with seizures and treated for. Cause of death was probably due to progression of seizures in this geriatric dog. A relation to the product is therefore unlikely.