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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-1119

2. Registrant Information.

Registrant Reference Number: 2009TH060

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

Address: 77 Belfied 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.

20-NOV-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

30-OCT-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 FLEA ADULTICIDE FOR CATS 8 WEEKS AND OLDER WEIGHING OVER

  • 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 as per label. Product was applied at veterinary clinic. This pet has no medical history with the clinic that dispensed the product and was not examined. The clinic cannot determine if the pet was ill prior to product use.

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

Cat / Chat

3. Breed

Domestic Short Hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

10

lbs

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
    • Symptom - Weight loss
  • Blood
    • Symptom - Hyperbilirubinemia
    • Specify - elevation of bilirubin
  • Liver
    • Symptom - Elevated liver enzymes
    • Specify - elevation of liver enzymes
  • Blood
    • Symptom - Leukopenia
    • Specify - mild lymphopenia,

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

Product was applied Oct 29, owner reports illness began Oct 30 but cat was not presented to the veterinarian for examination until November 20. Changes to bloodwork are consistent with a cat that has not been eating well. Dr does not feel clinical signs or changes on hematology are related to advantage use. Cat was treated with antibiotics and subcutaneous fluids. Recovery is on-going. Exposure is shown as 4 week or greater as advantage has effectiveness for at least 4 weeks.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Called clinic for update, cat was euthanized on Nov 30. Clinic declined post-mortem as does not believe this cat's illness was related to advantage.