Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2024

2. Registrant Information.

Registrant Reference Number: 2015CK045

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

Address: 2920 Matheson Boulevard

City: Missisaugua

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.

07-APR-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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
  • PERMETHRIN

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PMRA Registration No. 25131      PMRA Submission No.       EPA Registration No.

Product Name: Advantage 100

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

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).

A 7yr FS 63lb wolf/malamute hybrid was treated with 1 tube of advantage 100 in february 2014. On March 9th 2015, the dog was treated with 1 tube of Advantage 100 or K9 Advantix (unknown). The product was applied between the shoulder blades and at the base of the tail.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

cross breed dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

63

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

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Lameness

• Skin
  • Symptom - Pain

• General
  • Symptom - Abnormal behaviour

• Gastrointestinal System
  • Symptom - Other
  • Specify - difficulty drinking

• Nervous and Muscular Systems
  • Symptom - Convulsions
  • Symptom - Skittish
  • Specify - skittish

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

Unknown/Inconnu

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

Immediately after product application, the owner reports the dog had a seziure. The dog had 'convulsions' mainly affecting the left side. The dog began limping and had sensitive skin (painful to touch). The owner bathed the dog in a lake. The next day the dog continued to limp, and had difficulty drinking (lay down to drink). Currently the dog is greatly improved but is "skittish" and is has a mild limp affecting the left side (unknown which leg). The dog has not been examined by a veterinarian. Note the caller originally stated that she applied Advantage for ticks on March 9th 2015. At first she was insistent she had used Advantage. During a later conversation she claimed she had used K9 Advantix. Later, she reverted to Advantage since the veterinary clinic where she purchased the product did not sell any K9 Advantix during the time of purchase. She stated that the tubes looked different to the Advantage 100 she had used in february of 2014. Therefore it is unclear exactly which product was applied.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Major

19. Provide supplemental information here