Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0901

2. Registrant Information.

Registrant Reference Number: 2015TH394

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.

01-DEC-15

5. Location of incident.

Country: CANADA

Prov / State: NEWFOUNDLAND

6. Date incident was first observed.

23-OCT-15

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. 27584      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II extra large dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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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

Bull terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

28.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Lesion

• Blood
  • Symptom - Other
  • Specify - neutrophilia and elevated globulins

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

Oct 20 2015 a pet owner applied 1 tube of advantage II XL to a 5 yr old MN 28.6 kg bull terrier. A few days later the pet owner noticed skin crusts (not limited to application site). ON exam his body from midline down is covered in small (ranging 1 mm - 2 cm ) seborrheic crusts that when removed are extremely painful and the skin underneath is raw and there are holes in the skin (like tiny bot holes). The rest of PE was normal skin scrapes and tape was negative. Blood work showed an elevated WBC count with a neurtophilia. and an elevated globulins. A cutaneous drug reaction was suspected. The dog responded to cephalexin and seborrhic shampoo baths and recovered within 30 days.

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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