Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6160

2. Registrant Information.

Registrant Reference Number: 2015KP276

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

Address: 2920 Matheson Bvd. East

City: Mississauga

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.

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. 11556-134

Product Name: k9 advantix 100

• 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.

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 an unknown date in approximately 2007, a 6 year old, 58 pound, neutered, female, Borzoi (Russian Wolfhound) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix 100 (Imidacloprid - Permethrin) 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

Borzoi (Russian Wolfhound)

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

58

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Seizure

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

Approximately 2 weeks post application, the dog had multiple seizures within 24 hours, and then remained asymptomatic. On an unknown date in 2014, when the dog was 14 years old, she passed away. No necropsy was performed. The reporting party did not call to report the death of this patient, but to inquire on the expiration date of the product. No more information expected. Case 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

It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. Time to onset of seizures is too long (2 weeks) therefore other causes are more probable. Death occurred 7 years after product application and was linked likely to advanced age of the dog. Time for reporting is very long (8 years after seizure occurrence, 1 year after death of the dog) as intent of the phone call to Bayer was to inquire about expiration date of product and not to report this event. Considering all aspects, product connection deemed to be unlikely.