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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0365

2. Registrant Information.

Registrant Reference Number: 2014CK045

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.

16-JAN-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-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 approximately 08-Sep-2013, an 18 year old, neutered, male, Domestic Shorthair feline of unknown weight, in unknown condition with no known concomitant medical conditions, was exposed to an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) 24 hours after the owner had applied it to the dog in the home. The dog is asymptomatic.

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

Cat / Chat

3. Breed

domestic short hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

18

7. Weight (provide a range if necessary )

Unknown

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Weight loss
  • Cardiovascular System
    • Symptom - Other
    • Specify - congestive heart failure

12. How long did the symptoms last?

Unknown / Inconnu

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 approximately 15-Sep-2013, the cat had lethargy and anorexia and weight loss.The cat was examined by a veterinarian and a thoracic radiograph was taken. The cat was diagnosed with congestive heart failure.Follow-up 9 Oct 2013: On approximately 17-Sep-2013, the continued to have clinical signs and diedl. A necropsy was not performed. No more information is expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Secondary contact with product via treated dog only assumed. Time to onset of signs, lethargy and anorexia, is too long (7 days) to rule in a product connection. Weight loss is likely a consequence of the inappetence. The cat died on the way to the clinic for his euthanasia. Time to onset for death is also very long (10 days). No necropsy was performed. Other causes are more likely, such as the concomitant medical condition the cat was diagnosed with: congestive heart failure. The cat was also very old. Considering all aspects, a product connection is considered unlikely.