Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4575

2. Registrant Information.

Registrant Reference Number: 2013AM192

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. 11556-125

Product Name: Advantage II Medium 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.

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

Maltese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Vomiting

• General
  • Symptom - Hesitancy to move
  • Specify - reluctant to move

• Nervous and Muscular Systems
  • Symptom - Collapse

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 unspecified date in Mar2013 a 10 year old, 10.11 pound, neutered, male, Maltese canine, in fair condition, was examined by a veterinarian and diagnosed with a collapsed trachea. The dog was prescribed an unknown antibiotic. The dog was administered 1 tube of Advantage II Medium Dog (Imidacloprid- Pyriproxyfen) once topically by the owner. On 05Apr2013 the dog was reluctant to move,vomiting, lethargic and anorexic. The dog was not examined by a veterinarian. On 08Apr2013 the dog recovered from the clinical signs. On 13Apr2013 the dog collapsed and died. A necropsy was not 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

Direct topical dermal exposure of the product to the dog. Although unknown application date, duration to onset time considered quite long. Initial signs were unspecific and could have numerous other causes. No reaction to previous exposure. Sudden collapse and death not expected with product use as inconsistent with products pharmacological profile. Concomitant trachea collapse however could have caused collapse and sudden death. Considering all aspects a relation to the product is unlikely.