Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4007

2. Registrant Information.

Registrant Reference Number: 2015KP124

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. 11556-142

Product Name: k9 advantix II medium 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.

1

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 01-Oct-2014, a 7 year old, neutered, female, Schnauzer (Miniature) canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Medium 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Schnauzer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

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

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Swelling
  • Specify - Facial Swelling
  • Symptom - Anaphylactic shock

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 15Oct2014, the dog presented to the veterinarian for annual examination. The dog was administered a distemper vaccine, rabies vaccine, bordetella vaccine, and lyme's disease vaccine. Approximately four hours following the administration of vaccines, the dog began to have facial swelling and pruritus. The dog presented to the veterinarian and was administered an injection of diphenhydramine. The dog was then released into the owners care. Approximately 2 hours later the dog went into anaphalaxis shock and died. No necropsy was performed. No more information is expected and the 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

Facial swelling and anaphylactic shock reported later might represent hypersensitivity reaction. However signs are not expected as time onset after product application is quite long (14 days). Pruritus is not expected either to be generalized but rather be linked to the application site. Other causes are more probable, e.g. allergies, parasites or concurrent administration of vaccines reported. Sudden death is not expected in a dog after product application, as it is inconsistent with the pharmacotoxicological product profile. Weight is unknown and necropsy was not performed. Moreover, it is clearly reported that the signs occurred long time after Advantix application and shortly after the use of concurrent vaccines which might have further lead to its death. Considering overall aspects, a product connection is deemed to be unlikely.