Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2880

2. Registrant Information.

Registrant Reference Number: 2010CP022

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.

02-APR-10

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

29-DEC-09

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. 27600

Product Name: K9advantix55

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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).

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

german wire haired pointer

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.6

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

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

DEC 2009:Caller states that they applied this product to their dog 5 days ago for the first time. Starting one day after the application, the dog became lethargic and was not eating, the owners did find ticks on the dog at the time of application. They brought the dog to the DVM two days after the sxs developed and the dog was placed on prednisone and doxycycline, but no blood work was done. The DVM has told the owner that the dog could be ill from the ticks, or the Advantix. The dog is still not eating or drinking. -Other. Jan 10, 2010 10:18AM Callback: Owner took dog to clinic. DVM treated symptomatically but owner did not know what treatments were performed. Dog died overnight and DVM could not determine the cause of death.

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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

Observed signs rather unspecific in dogs and may have multiple potential causes. Though lethargy may exceptionally occur in particular sensitive dogs, in this case vet suspects potential relation to ticks or transferred disease. Death definitely not consistent with pharmaco-toxicological product profile. Although no necropsy performed and vet does not know specific death cause, other causes or unknown underlying disease more likely.