Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6076

2. Registrant Information.

Registrant Reference Number: 2014CK366

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 XL

• 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.

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).

Sometime approximately in Aug 2012, a feline of unknown signalment, female, in unknown condition, with no known concomitant medical condition, was administered an unknown amount of Advantage II Extra Large Dog (imidaclopridpyriproxyfen) topically by the owner

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Other
  • Specify - teeth disorder

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 the patient had teeth disorder.Sometime on approximately Sep 2012 the patient died of unknown causes. No necropsy was performed. No more information is expected. This case is closed.

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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 reported signs (such as teeth disorder and death) are not expected after product application, as inconsistent with pharmaco-toxicological product profile. The product was used off label. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Reliability of data is questionable due to limited information (animal details and chronology not available). Other etiologies are more probable. No signs of allergy/anaphylactic reaction reported. Exact time to onset is unknown but seem long. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. No necropsy was performed. In the end, product involvement was ruled out for serious outcome and considered unlikely.