Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6071

2. Registrant Information.

Registrant Reference Number: 2014CK355

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.

11-JUL-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. 11556-127

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 approximately 10Jul2014, a 8 year old, 25 pound, neutered, female, Beagle crossbred canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Dog (Imidacloprid-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

cross breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

25

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Hives

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy
  • Symptom - Adipsia

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 11Jul2014 the dog developed generalized urticaria, lethargy, anorexia and adipisia. The dog was not examined by a veterinarian.On approximately 18Jul2014 the dog passed away from unknown causes. 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

In individual cases hypersensitivity reactions (e.g. urticaria) to the product are possible in animals that are particular sensitive. Although sign is rather unspecific, lethargy may exceptionally occur in particular sensitive animals. Anorexia and adipsia likely only consequence of lethargic status. Onset time is consistent for signs. Death not expected after product application, as inconsistent with pharmacotoxicological product profile. Reliability of data is questionable due to limited information (medical history, chronology and necropsy not available). Other etiologies are more probable. No signs of allergy/anaphylactic reaction reported. Though time to onset 8 days, death is inconsistent with the pharmacological product profile. Cause for death unrelated to product use. In the end, product involvement was considered unlikely.