Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2193

2. Registrant Information.

Registrant Reference Number: 2017KP137

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.

19-APR-17

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 8.8 %
  • 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.

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).

On an unknown date in Mar-2016, a 13 year old, female,Shetland Sheep Dog (Sheltie) canine, of unknown weight,reproductive status, and condition, with no known concomitant medical conditions, was administered 1 tube ofK9 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Shetland Sheepdog (sheltie)

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

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

Unknown / Inconnu

11. List all symptoms

System

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

• Renal System
  • Symptom - Renal failure

12. How long did the symptoms last?

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

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

On an unknown date post administration in Mar-2016, the canine was examined by a veterinarian had a positive test result for lyme borreliosis, was diagnosed with renal failure, and died. It was unknown if any treatments were performed if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss another dog and was not to report the death of the patient. No more information is expected. This case is closed. 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 renal failure is not expected in a dog after product application, as it is inconsistent with pharmacotoxicological product profile. Sign is likely linked to diagnosed Lyme borreliosis. Death is not expected either and the geriatric dog likely died due to reported renal failure. Actually, the reason for the initial call was to discuss another dog and was not to report the death of the patient. Moreover, previous applications were well tolerated. No ticks were reported and thus unclear when the dog contracted the Borreliosis. Moreover, Borreliosis has a long incubation period (1-5 months) therefore the animal could have contracted the disease before Advantix application. Finally, though necropsy details and time to onset are unknown, overall, considering the known product profile, a product connection is deemed to be unlikely.