Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-5325

2. Registrant Information.

Registrant Reference Number: 1200858

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

Address: 295 Henderson Drive

City: Regina

Prov / State: SK

Country: Canada

Postal Code: S4N 6C2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

06-JUL-13

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

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: DECIS Insecticide (unspeciifed)

• Active Ingredient(s)
  • DELTAMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Potato field

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Mixed Breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

50.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Fever

• 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.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

36

Hour(s) / Heure(s)

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

July 6, 2013: Received a call from a veterinarian that was treating a dog that presented to the clinic on July 5 with a history of recurring grand mal seizures over the previous 24 hours. The DVM has treated with IV fluids, methocarbamol, atropine and diazepam, but the dog has remained minimally responsive to therapy. The recurring seizures continue. The dog is now hyperthermic. The owners related that a potato field near there property had been sprayed on July 4 with a pesticide called Decis made by Bayer. The exact formulation was not known. The dog does not have access to this field but the owners speculate that the pesticide may have somehow gotten on their product such that the dog could of had an exposure. Follow-up was completed with the DVM on July 11. She reported then that she treated symptomatically and sent the dog home after 1.5 days of treament though he hadn't completely recovered. She has tried to contact the pet owner several times but has not received any follow-up from them. DVM does not think the signs are related to the product and feels there is another underlying etiology. Follow-up was again completed with the DVM on September 3, 2013. The DVM had finally received follow-up from the owner yesterday. The owner reported then that the dog had died on July 7. The DVM again reported that she did not think that the Decis was responsible for the dog's illness.

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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

This incident was not determined to have a fatal outcome until September 3, 2013, prompting a submission of a 30-day report to the PMRA in September 2013.