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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-1123

2. Registrant Information.

Registrant Reference Number: 2009TH064

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.

21-DEC-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-DEC-09

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)

PMRA Registration No. 25129      PMRA Submission No.       EPA Registration No.

Product Name: Advantage 18

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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).

Product was applied to pet on back of neck. Pet was given an advantage 18, an advantage 9 should have been used as the cat is only 3 kg.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Long Hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

3

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 - Hair loss
  • Eye
    • Symptom - Conjunctivitis
  • Skin
    • Symptom - Itchy skin
    • Symptom - Other
    • Specify - pyoderma

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?

No

14. b) How long was the animal hospitalized?

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

Received information for "Charlie" See from Dr (name). Cat has chronic URTI issues. Was dispensed advantage Nov 30. Owner had cat seen Dec 1 for bothering at right eye, cat is mostly indoor, Dr noted conjunctivitis of right eye. Vaccines given, no other treatment. Dec 8 cat seen again for facial pruritus of 5 days duration, has scabs under chin and alopecia around ear. Dr though might be reaction to advantage and prescribed prednisolone and cleaned area. Also put on bioclav starting Dec 14.


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. Length of exposure is shown as greater than one month as advantage has at least 4 weeks efficacy. Cat is recovering well but not yet fully recovered. A full recovery is expected.