Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0549

2. Registrant Information.

Registrant Reference Number: 2017KP057

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.

06-OCT-16

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 approximately 03-Oct-2016, a 7 year old, 15.6 pound,neutered male, Pomeranian canine, 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

15.6

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Diarrhea
  • Symptom - Other
  • Specify - Gastritis

• Liver
  • Symptom - Other
  • Specify - Hepatic disorder

• Cardiovascular System
  • Symptom - Cardiac arrest

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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 06-Oct-2016, the dog developed vomiting and diarrhea. On 07-Oct-2016, the dog was found deceased. On approximately 26-Oct-2016, a necropsy was performed and revealed mild to moderate gastrits, mild hepatic changes, and unspecified cardiac changes. No more information is expected. Case is closed. Note: The reason for the call to BAH was not to report the death of this patient but to inquire on product use on another dog.

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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 vomiting and diarrhoea are unspecific signs and may have numerous other causes in dog. No oral product exposure reported. Death is not expected after product application. Time to onset over one day (4 days), therefore allergic/anaphylactic reaction can be ruled out. Necropsy revealed gastritis, hepatic and cardiac disorders which may have contributed for reported signs and death of the animal, as signs are inconsistent with pharmacotoxicological product profile. Moreover the reason for the call to BAH was not to report the death of this patient but to inquire on product use on another dog. Other causes more probable. Considering all aspects, a product connection is deemed to be unlikely.