Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2073

2. Registrant Information.

Registrant Reference Number: 2011TH012

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

Address: 77 Belfield Road

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

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

Domestic Animal

4. Date registrant was first informed of the incident.

08-APR-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

29-MAR-11

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. 27658      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 10

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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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).

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

Toy Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

4.2

kg

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite

• Skin
  • Symptom - Paresthesia
  • Symptom - Lesion

• General
  • Symptom - Adipsia

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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

Owner applied product Mar 28 2011. Owner gave dose of Sentinel orally Mar 29 2011. Owner noticed that within a day of applying K9 advantix the dog seemed lethargic, maybe confused or disoreinted. Just standing, not chasing ball as usual. Not eating or drinking for about 2 days. Dog was itchy at application site approx 2 days after application. Dog was bathed with Earth Bath puppy shampoo April 8. Dog was still somewhat itchy, lethargic and inappetant April 8. Pet was examined by Dr April 8. 2 small scabs ( 1 cm x 0.5 cm) were noted at the back of neck with some inflammed skin around them. The area was washed with dish soap and 800 mg capsule of vit E oil was applied. Owner was also prescribed hydrocortisone cream to use on pet if needed. O reports dog recovered by April 11 2011. Never used hydrocortisone cream.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Classed as moderate as treatment was given. Exposure is listed as greater than 1 week as product would not have been removed by Earth Bath shampoo. Not removed until dish soap was used. Unable to determine if administration of Sentinel contributed to lethargy, inappetance etc.