Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-3819

2. Registrant Information.

Registrant Reference Number: 2012TH117

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.

17-AUG-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

05-AUG-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. 25127      PMRA Submission No.       EPA Registration No.

Product Name: advantage 55

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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

Scottish Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

24.6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Bizarre behaviour

• Skin
  • Symptom - Hives

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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?

.5

Day(s) / Jour(s)

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

Owner gave dog a flea bath (product unknown) and then applied Advantage on Aug 3 2012. Aug 5 the owner thought the dog had become lethargic and was fly catching (snapping at the air as if there were flies to catch). The owner had also noted that the dog had hives and was not eating well. The dog was bathed and given benadryl on Aug 6 and was examined on Aug 7. On exam the dog was normal on exam but was placed on IV fluids and given dexamethasone and kept for observation for the day. The dog was sent home Aug 7 and had eaten well in hospital. No fly catching was seen. The owner was contacted for an update Aug 8 and reported the dog ate overnight and only a few episodes of fly catching were noted.

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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