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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0777

2. Registrant Information.

Registrant Reference Number: 2010CP097US

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.

19-NOV-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: advantage18

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %

7. b) Type of formulation.

Liquid

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).

Caller states he applied Advantage 18 and Capstar to cat on 11-17-10.

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

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 )

11

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Other
    • Specify - fatty liver disease
  • General
    • Symptom - Weakness
  • Respiratory System
    • Symptom - Tachypnea
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

The day after application, the cat was weak/lethargic and had tachypnea. The cat was examined by DVM and after Xrays DVM felt cat had a tumor or intestinal blockage. Caller reports the cat was found to have what was suspected as a hairball or something the DVM felt the cat could pass. The cat was sent home and the following day the cat was seen at clinic again at which time the caller was told the cat has fatty liver diease. DVM recommended a feeding tube. When caller returned to clinic was told the cat had died. No necropsy was performed


To be determined by Registrant

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

Death

19. Provide supplemental information here

Initial signs were non-specific and may have multiple other possible causes. Another product was given concurrently and may have contributed to observed signs. However, the cat suffered from other severe underlying medical problems, e.g. intestinal blockage/tumour and fatty liver disease that likely were responsible for the cat`s death but unrelated to product use.