Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3249

2. Registrant Information.

Registrant Reference Number: 2013AM154

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.

13-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

04-OCT-11

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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-125

Product Name: Advantage II medium dog

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

---

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

One vial of Advantage II medium dog was applied topically by the owner to one spot on the dorsal midline.

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

Crossbreed

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Restlessness

• Gastrointestinal System
  • Symptom - Diarrhea

• Blood
  • Symptom - Bleeding
  • Specify - blood coming from its mouth

12. How long did the symptoms last?

Unknown / Inconnu

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

The owner applied the Advantage II for Medium Dogs to the dog on 9/28/11. On 10/4/11 the owner noticed that the dog was acting restless and lethargic. Throughout the week the lethargy worsened. On 10/7/11 the dog started having diarrhea. On 10/9/11 the owners found the dog passed away with blood coming from its mouth. The dog was taken by animal control and the status of the remains are unknown. This was the first time use of the product. The puppy had been purchased through a pet store a few months ago but had never had any type of veterinary care. Update 20.10.2011: Technical assessment: The batch was manufactured and released according to specifications. No deviations occurred. We cannot perform further investigations because no complaint sample is available. We did not perform an analysis of the retention sample because it would not have provided additional information. The certificate of analysis is attached to the complaint.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Unlikely product-related as inconsistent with the pharmacological and toxicological product profile. Onset time of 6 days for the first signs allows the exclusion of a product relation. Although no post-mortem examination performed, death 11 days after application of product is not product related. The technical revision of the complained batch did not reveal any deviation from the specification.