Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4531

2. Registrant Information.

Registrant Reference Number: 2013AM210

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-AUG-13

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 8.8 %
  • PYRIPROXYFEN
    • Guarantee/concentration 44 %

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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).

One vial of Advantage II extra large 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

Doberman

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

95

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Anorexia

• Cardiovascular System
  • Symptom - Other
  • Specify - congestive heart failure

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

On an unknown date in Jun2012, a 7 year old, 95 pound, neutered, male, Doberman Pinscher canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) once topically by the owner. On the same day the dog became anorexic, and the dog was off food for approximately 3 days. The the dog recovered with out treatment. On an unknown date in Jul2012, the owner attempted to apply a dose Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) the dog hide from the owner when it saw the tube. The owner discontinued use of the product. The dog recovered by the next day with out treatment. On an unknown date in Oct 2012 the dog died of congestive heart failure. It is unknown if a necropsy was performed. The owner initially contacted Bayer Animal Health to seek advise about another product being used on other dogs in the home and not to report the death of this pet.

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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 information regarding the death of the dog was casually provided during an inquiry. Reporting of occurrence over almost one year after product application, thus occurrence of fatal outcome not within close time of product application. Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg / kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Death cause of this dog was due to congestive heart failure according to case description. Duration to onset time more than 3 months after last exposure. Chronology inconsistent. Therefore a product relation is considered unlikely.