Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3127

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0021758 (Report 563028)

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.

13-MAY-19

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

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: K9advantixII 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 an unknown date in approximately 2016, a dog with unknown signalment, 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

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Parasitism
  • Specify - Other abnormal test result NOS
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 approximately 2016, the dog died. It is not known if the dog was evaluated by a veterinarian. A necropsy was not performed. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed. Follow up received on 13th May 2019: On an unknown date in approximately 2016, the dog had a positive test for a tick born illness and died. It is not known if the dog was evaluated by a veterinarian. A necropsy was not performed. The intent of the call was to inquire about product use in general and not to report this event. 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 Reported tick born illness is not expected after product application. No ticks were reported and thus unclear when the dog contracted any disease. Moreover type of illness is not specified. Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Moreover death is likely associated with tick borne disease. Very low level of information (age, medical history and time to onset unknown - necropsy not available) Very long time for reporting as the intent of the call was to inquire about product use in general and not to report this event. No signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Other etiologies more probable. Considering all aspects, product connection deemed to be unlikely.