Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1718

2. Registrant Information.

Registrant Reference Number: 2012BS211

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

Address: 77 Belfield Rd

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.

30-NOV-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-NOV-12

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. 27661      PMRA Submission No.       EPA Registration No.

Product Name: K9 ADVANTIX 20 FLEA AND TICK ADULTICIDE

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 November 27 2012, 1 tube of K9 Advantix 20 was applied dorsal midline to 1.5 year old Cavalier King Charles Spaniel by owner. Was also applied to other dog in household at same time. See 2012BS212

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Cavalier King Charles Spaniel.

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

23.46

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

• Skin
  • Symptom - Itchy skin
  • Symptom - Erythema

12. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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

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

Within 15 minutes of application dog became itchy and developed erythema. The other dog is the household was itchy as well but recovered within a day (See 2012BS212) On Nov 29 2012 the dog was examined by vet, still itchy with erythema. Vit E oil was applied and dog eventually recovered by Nov 4 2012.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

See case 2012BS212

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Cavalier King Charles Spaniel

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

21.4

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin

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

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

Within 15 minutes of application dog became itchy but recovered in 24 hours. The other dog in the household had a reaction as well.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here