Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4192

2. Registrant Information.

Registrant Reference Number: 2016KP096

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.

18-JUL-16

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. Unknown

Product Name: k9 advantix unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 an unknown date 2004, a 1 year old, 16 pound, neutered,female, Pug canine, in good condition, with no known medical concomitant conditions was administered 1 tube of K9Advantix (unspecified) (Imidacloprid - Permethrin) 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

Pug

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

16

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Hives

• Liver
  • Symptom - Other
  • Specify - Congenital hepato-biliary disorders

12. How long did the symptoms last?

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

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

Approximately 3 hours post application the dog broke out in hives. The dog was examined by a veterinarian, and was administered an unknown cortisone injection. Approximately 2 days post application, in 2004, the dog recovered. On an unspecified date in 2008, the dog was diagnosed with a liver shunt. An unspecified time post diagnosis, in 2008, the dog died. No known necropsy was performed. No more information is expected. This case is closed. Note: intent of call was likely to report the serious event occurring recently in 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

Though reported hives may reflect hypersensitivity reaction to the product, later reported liver shunt is not expected after product application as it is inconsistent with pharmaco-toxicological product profile. Death is not expected either and is likely a consequence of reported liver shunt. Moreover, reporting occurred an exceptionally long time (approximately 8 years) after death as probably reported concomitantly to the serious event occurring recently in another dog. Even though no necropsy was performed and time to onset is short for initial sign, considering very long time to onset (approximately 4 years) for unexpected serious sign and fatal outcome, a product connection is deemed to be unlikely.