Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4050

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0015067

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.

30-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

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: K9advantix II pipette size unknown

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

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7. b) Type of formulation.

Other (specify)

Spot-on

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 2017, a 15 year old Yorkshire Terrier crossbred canine of unknown sex and weight, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier crossbred

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

15

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Neoplasia

• Gastrointestinal System
  • Symptom - Other
  • Specify - Pancreatitis

• General
  • Symptom - Death

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 approximately 2017, a 15 year old Yorkshire Terrier crossbred canine of unknown sex and weight, in unknown condition, with concomitant medical conditions of pancreatitis, and a splenic mass, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner. On approximately 2017, 2.5 weeks after product application the dog was diagnosed with a tumor on the spleen and pancreatitis. by the veterinarian. It is unknown if any treatments were provided. On an unspecified date in 2017 the dog passed away. It is unknown if a necropsy was performed. No further information is expected. This case is closed Follow up received on 12 Apr 2017: case description revised as follows: On approximately 2017, a 15 year old Yorkshire Terrier crossbred canine of unknown sex and weight, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner. On approximately 2017, 2.5 weeks after product application the dog was diagnosed with a tumor on the spleen and pancreatitis. by the veterinarian. It is unknown if any treatments were provided. On an unspecified date in 2017 the dog passed away. It is unknown if a necropsy was performed. No further information is expected. This case is closed

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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

N - Unlikely Tumor on the spleen, pancreatitis and further reported death are not expected after product application as inconsistent with pharmaco toxicological product profile. Time to onset is rather long (2.5 weeks). Death likely related to a diagnosed medical status. Moreover the dog was of advanced age. Considering long time to onset for an anaphylactic shock, a product relation is deemed to be unlikely.