Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4092

2. Registrant Information.

Registrant Reference Number: 2015KP119

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Blvd. East

City: Toronto

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.

20-JUL-15

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. 11556-144

Product Name: k9 advantix II Extra Large dog

• 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 01 Jun 2012, a 12 year old, 85 pound, neutered, male, Retriever Labrador (No description) canine, in good condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large 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

Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

85

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Other
  • Specify - Circulatory disorder
  • Symptom - Other
  • Specify - Cardiac Enlargement

12. How long did the symptoms last?

Unknown / Inconnu

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 application, in Jun 2012, the dog fainted. The dog was examined by a veterinarian and diagnosed with an enlarged heart. On an unknown date post diagnosis, in Jun 2012, the dog was examined by a cardiologist, had an echocardiogram, a cardiac ultrasound, and chest radiographs (results unknown), and placed on a regimen of an unknown amount of clopidogrel bisulfate, an unknown amount of acetylsalicylic acid, and received an unspecified amount of a whole blood transfusion. On 01 Jul 2012, the dog was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) topically by the owner. On 09 Jul 2012, the dog died at home. No necropsy was performed. Follow-up received on 18th May 2015: No more 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

Note from LDSM: No quality issues were noted upon product investigation. Reported cardio-vascular disorders and death are unexpected after product application as they are inconsistent with the pharmaco-toxicological product application. Medical history was not known and necropsy was not performed. Moreover, the diagnosed cardiac enlargement might be due to its geriatric condition and possibly may have contributed to its death. Even though the time to onset for cardio-vascular disorders was unknown, considering all aspects, a product connection is deemed to be unlikely.