Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6100

2. Registrant Information.

Registrant Reference Number: 2014CK387

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.

18-SEP-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. 11556-128

Product Name: Advantage II small 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.

.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 18-Sep-2014, a 7 month old, 7.00 pound, intact, female,Terrier (Rat) / Poodle (Toy) crossbred canine, in good condition with a concomitant flea infestation, was administered 1 tube of Advantage II Small 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 )

0.6

7. Weight (provide a range if necessary )

7

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

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Tachypnea

• Nervous and Muscular Systems
  • Symptom - Paresis

• Respiratory System
  • Symptom - Respiratory failure

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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

Approximately 20 minutes post application, signs of tachypnea and limb weakness were observed. Approximately 40 minutes post application, signs of respiratory arrest with death were observed. No necropsy was 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

respiratory arrest not expected after product application as inconsistent with product pharmacotoxicological profile. Limb weakness not expected after product Reported respiratory sign tachypnea and subsequentapplication, consistent time to onset however likely coincidental. Death not expected after product application, as inconsistent with pharmacotoxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by dogs without showing any side effect. No necropsy done. Other causes more probable. Time to onset short, allergic/anaphylactic reaction cannot be ruled out. In the end, a product relation remains unassessable.