Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4219

2. Registrant Information.

Registrant Reference Number: 2016KP123

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

18-JUL-16

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. Unknown

Product Name: k9 advantix II Unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 approximately 01-Apr-2016, a 9 year old, 4 pound,female, Yorkshire Terrier canine, of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II(unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

4

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Other
  • Specify - Abnormal Test Results

12. How long did the symptoms last?

Unknown / Inconnu

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

No

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

On an unknown date in Apr 2016, the canine was diagnosed with Lyme disease and died secondary to the Lyme disease. No necropsy was performed. No further information expected. This case is closed. LDSM: The intent of the call was to discuss use of the product on another pet and not to report the death of the dog. Note: Previous applications well tolerated.

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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

Reported death is not expected in a dog after product application, as it is inconsistent with pharmacotoxicological product profile. Previous applications were well tolerated. Moreover, it is stated that dog died of Lyme disease. No ticks were reported and thus unclear when the dog contracted the Lyme disease. Moreover Lyme disease has a long incubation period (1-5 months) therefore the animal could have contracted the disease before Advantix application. Actually, the intent of the call was to discuss use of the product on another pet and not to report the death of the dog. Finally, though no necropsy was performed and time to onset for death is not provided, considering the known product profile, a product connection is deemed to be unlikely.