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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6172

2. Registrant Information.

Registrant Reference Number: 2010CP062US

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.

18-OCT-10

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

05-SEP-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.       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?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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

Other / Autre

specify guinea pig

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.1

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • General
    • Symptom - Death

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?

Other / Autre

specify K9advantix was applied to a dog on Sep 03;

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 5Sept2010 the 2 month old, unknown sex, Guinea Pig started to drool had an seizure and died.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Level of information rather low. No direct or indirect exposure to product or potential way of indirect contact between guinea pigs and dogs described. Unusual scenario thinking of 2 month old guinea pig licking off product of treated dog. Furthermore, two days between treatment of dogs and onset of signs in guinea pig rather long and would underline other cause to be more likely involved as product on dogs fur should have dried up in meantime. Oral LD50 for permethrin in guinea pig is 4.000 mg/kg BW, and of imidacloprid in rat is also 4.000 mg/kg BW