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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0373

2. Registrant Information.

Registrant Reference Number: 2014CK053

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.

Unknown

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. 11556-143

Product Name: K9 Advantix II (large 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.

2.5

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 an unknown date in 2013, a 8.5 year old, neutered, male, Australian Shepherd canine, of unknown weight, in good condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Large 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

australian sheperd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.5

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Blood
    • Symptom - Bleeding
  • Unknown
    • Symptom - Other
    • Specify - autoimmune disease
  • General
    • Symptom - Abnormal behaviour

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 an unknown date in Apr-2013, the dog exhibited a behavioral change and was bleeding from his mouth, nose and ears (Haemorrhage NOS). The dog was examined by a veterinarian and diagnosed with allergies. A number of unknown medications were prescribed. The day after the onset of clinical signs, the dog was examined by another veterinarian and diagnosed with an autoimmune disorder.On 05-Jul-2013, the dog died. No known 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

Reported symptoms of bleeding from nose, mouth and ears and autoimmune disorder and death are not expected after product application, as inconsistent with pharmacotoxicological product profile. Other causes for hemorrhage are more probable, i.e. intoxication with Vitamin K antagonists, other coagulation disorder. The attending veterinarian diagnosed an autoimmune disorder, probably the cause for the hemorrhage. Described behavioral signs rather of secondary nature. Time to onset of signs is unknown; approximately 3 months after onset of signs the dog died. The reason for death is unknown, and no necropsy was performed, however a connection to diagnosed autoimmune disorders seems likely. Animal died more than 3 month after last product application. Previous application well tolerated. Considering all aspects, a product connection is deemed to be unlikely.