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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-1122

2. Registrant Information.

Registrant Reference Number: 2009TH063

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.

10-DEC-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-NOV-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).

Owner applied product to cat Nov 27 2009.

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 shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

5.1

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Fever
    • Symptom - Lethargy
  • Renal System
    • Symptom - Urinary incontinence
  • Blood
    • Symptom - Leukocytosis
    • Specify - mild neutrophilia
  • General
    • Symptom - Abnormal behaviour
    • Specify - urinating outside of litter box

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

Owner applied product to each of her 11 cats. This cat has a history of trauma to the tail in June 2009 that resulted in urinary incontinence that persisted for several months. The owner contacted the clinic Nov 30 to advise the cat had not been eating well since the advantage was applied Nov 27. The cat began urinating outside the litter box on Dec 1. The cat is an indoor/outdoor cat. The cat was examined Dec 4 2009 and was febrile on exam and had a mild neutrophilia. Other bloodwork was normal and a urinalysis showed no abnormal findings. The cat was treated with 0.5 ml of convenia SQ, 0.1 ml of metacam SQ and 120 ml of fluids SQ. The owner reported the cat was back to normal and eating well within an hour of treatment.


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. The length of exposure is shown as greater than one month as advantage has at least 4 weeks activity and was not removed from the cat.