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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0775

2. Registrant Information.

Registrant Reference Number: 2010CP095US

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.

11-JAN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-OCT-10

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
      • Guarantee/concentration 9.1 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 1/2 tube of Advantage18 to her cat on 1Oct10. Several hours later, the cat threw up. Over the weekend, the cat slowly lost her ability to walk; she wouldn't eat or drink. Cat also was cold and couldn't regulate her body temperature. Owner bathed cat 2Oct10. This morning, 4Oct10, the cat died. The cat has an unknown medical history, as the cat had never been seen by the veterinarian. Owner applied product to her other 2

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

domestic

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.9

7. Weight (provide a range if necessary )

Unknown

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • General
    • Symptom - Hypothermia
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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

Several hours after application, the cat threw up. Over the weekend, the cat slowly lost her ability to walk; she wouldn't eat or drink. Cat also was cold and couldn't regulate her body temperature. Owner bathed cat 2Oct10. This morning, 4Oct10, the cat died. The cat has an unknown medical history, as the cat had never been seen by the veterinarian. Owner applied product to her other 2 cats at the same time with no adverse reactions observed


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported signs are non-specific and may have multiple potential other causes. Vomiting and other signs are not expected following appropriate topical product administration. Even when product was ingested, signs and especially death would not be expected. The cat`s past medical history is unknown and no lab exams were performed to clarify underlying conditions.