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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2051

2. Registrant Information.

Registrant Reference Number: 2011CP001US

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.

02-MAY-11

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

13-JAN-11

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9advantix

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %

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).

an unknown amount of K9advantix was applied to a dog

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

chihuahua cross

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.1

7. Weight (provide a range if necessary )

1

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 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 - Vomiting
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Lethargy
    • 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?

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

Hours after application of the product Lulu began vomiting. Lulu was taken to the vet clinic on 14 Jan 2011 where she was bathed and treated with fluids and dextrose. 15 Jan 2011 she was taken back to the vet and treated again with more fluids and dextrose because she wasn't any better. Lulu then began having seizures, she became very lethargic, and wanted to be left alone. The owner reports that Lulu suffered for a week with vomiting, diarrhea, and seizures before she then passed on 21 January 2011


To be determined by Registrant

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

Death

19. Provide supplemental information here

Pipette size and thus applied dosage not known. Product applied very young and low-weight dog. Vomiting and diarrhoea are rather unspecific in dogs and may have multiple potential causes. They are not expected following topical application of product. Potential oral ingestion was not reported. Neither imidacloprid nor permethrin which are both active ingredients in the product Advantix have the potential to provoke seizures in dogs neither alone nor in combination when administered topically. Considering furthermore the persistence of signs as well as the final death other causes to be considered first in this puppy.