Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0538

2. Registrant Information.

Registrant Reference Number: 2017KP046

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.

27-JAN-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. 11556-128

Product Name: k9 advantix II small dog

• 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.

.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).

Minimal information was obtained at the time of the call. Due to the nature of the call, no further information will be received.On an unspecified date, in approximately 2015, a Chihuahua canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Small Dog (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

Chihuahua

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?

>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 - Lethargy
  • Symptom - Death

• Skin
  • Symptom - Pruritus

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 post application, in approximately 2015, the canine developed application site pruritus and lethargy. On an unspecified date, in approximately 2016, the dog died of unknown causes. A necropsy was not conducted. The reporting party contacted Bayer to discuss a different product on another pet in the home and not to report the death of this animal. No additional information expected. 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

Application site pruritus may reflect discomfort caused by the applied product. Lethargy is unspecific and may have numerous other causes in dog. However, later reported death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. The reason for the initial call to Bayer Animal Health was not to report the death of the animal but to discuss a different product on another pet in the home. No signs of allergy/anaphylactic reaction reported. Time taken for reporting is long (10 months) as reporting of this adverse event likely done during the report of the linked recent adverse event in another dog with another product. Other causes more probable. Overall, considering all aspects, a product connection is deemed to be unlikely.