Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6079

2. Registrant Information.

Registrant Reference Number: 2014CK350

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. 11556-130

Product Name: Advantage II Extra large dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Advantage 100 Topical Solution

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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 Sep-2013, a 13 year old, unknown weight, female, German Shepherd Dog canine, in poor condition with a concomitant medical condition of a brain tumor, was administered 1 tube of Advantage 100 Topical Solution (Imidacloprid) topically by the owner.On an unspecified date in Oct-2013 the dog was administered 1 tube of Advantage II Extra Large dog (Imidacloprid, Pyriproxifen).

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

german shepherd dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

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 an unspecified date in November 2013 the dog died after complications from the brain tumor

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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. Reliability of data is questionable due to limited information (product and animal details, chronology, necropsy not available). Other etiologies are more probable, as the dog had brain tumor as a concomitant medical condition. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Time to onset exceptionally long. Dog's concomitant condition of brain tumor eventually lead to further complications and the dog died. It is unlikely that the product played any role in the event. The caller contacted Bayer Animal Health to inquire about using the remainder of the product on their pet and not to report this event. It is unknown if a necropsy was performed. In the end, product involvement was ruled out for serious outcome and product relation considered unlikely.