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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6320

2. Registrant Information.

Registrant Reference Number: 2013CK091

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.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

28-SEP-13

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. 11556-141

Product Name: K9 Advantix II Small dog

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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).

On 27-Sep-2013, a 8 week old, 5 pound, neutered, male, Coonhound (Black And Tan), in unknown condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin- Pyriproxyfen) once topically by the owner.

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

Coon hound

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.15

7. Weight (provide a range if necessary )

5

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

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Wheezing
    • Symptom - Dyspnea
  • Nervous and Muscular Systems
    • Symptom - Recumbent

12. How long did the symptoms last?

Persisted until death

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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

On 28-Sep-2013, the dog vomited. After the vomiting episode the dog was wheezing and had dyspnea. The dog became laterally recumbent and the dyspnea persisted until death later that day. 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

Vomiting 1 day after product application rather unspecific in dogs and may have multiple potential causes. It is not expected following topical application of product. Potential oral ingestion was not reported. Later occurring symptoms dyspnea and wheezing, lateral recumbence and death are not expected after product application as inconsistent with pharmaco-toxicological product profile. Other causes are more probable in a puppy of 8 weeks, particularly as vaccination and health status at the time of product application is unknown, i.e. acute infectious disease, unknown hereditary disease. Considering time to onset and no investigation performed, a product connection remains unassessable