Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6166

2. Registrant Information.

Registrant Reference Number: 2015KP282

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.

19-OCT-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-JUL-14

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 09-Jul-2014, a 11 year old, 90 pound, neutered, female, Retriever (Golden)/Boxer crossbred 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

crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

90

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Neoplasia

• Gastrointestinal System
  • Symptom - Weight loss

• Blood
  • Symptom - Other
  • Specify - Swollen lymph nodes

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 15 Jul 2014, the dog was examined by a veterinarian and dianosed with arthritis. On 09 Aug 2014, the owner administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) topically. On 25 Aug 2014, the dog was examined by a veterinarian and had a lazer treatment to the unspecified joints affected by arthritis. On 27 Nov 2014, the owner administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) topically. On 27 Dec 2014, the dog was examined by a veterinarian and diagnosed with anal gland carninoma. On 05 Jan 2015, the dog had an unspecified anethesia and surgical removal of the anal glands. The dog was placed, post operatively, on a regimen of an unspecified amount of oral carprofen and an unspecified amount of oral gabopentin for pain management. On 09 Jan 2015, the owner administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) topically. On 16 Jan 2015, the dog was anorexic, had enlarged lymph nodes and weight loss of 11 pounds. On 10 Ap 2015, the dog died at home. No necropsy was performed. 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

Arthritis, anal gland carcinoma and swollen lymph node are not expected as inconsistent with pharmacotoxicological product profile. Anorexia may be consequence of other signs. Weight loss may be due to anorexia. Death is not expected as well, and likely consequence of reported carcinoma. Moreover, dog was of advanced age. Time to onset for death is too long (4 months) after latest product application. Considering all aspects, product relation is deemed to be unlikely.