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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4543

2. Registrant Information.

Registrant Reference Number: 2013AM222

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.

13-AUG-13

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. 11556-125

Product Name: K9 Advantix 20

  • 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.

1

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).

One vial of K9 Advantix 20 was applied topically by the owner to one spot on the dorsal midline.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Schipperke

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

20

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • General
    • Symptom - Abnormal behaviour
    • Specify - sitting in the grass; wanter the owner to rub her back
    • Symptom - Hyperactivity

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 01-Jun-2009, a 16 year old, 20 pound, spayed, female, Schipperke canine, in poor condition, with a concomitant medical condition of unspecified medical issues, was administered 1 tube of K9 Advantix 20 (Imidacloprid - Permethrin) once topically by the owner. Immediately after application, the patient became restless, was sitting in the grass (behavioral), wanted the owner to rub her back (behavioral), and was running around (hyperactivity). On approximately 03-Jun-2009, the clinical signs resolved. An unspecified amount of time later, the patient died. It is not known whether or not a 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

While the described behavioural disorders, although unspecific, may be a consequence of the uncomfortable feeling caused by the applied product, one would not expect such a fatal outcome after product application as inconsistent with pharmaco-toxicological product profile. The dog was 16 years old and already in a poor state of health at time of treatment. It is stated that the dog was suffering from a concomitant medical condition of unspecified medical issues, so the cause of death is likely linked to the concomitant medical condition. The time to onset of death is unknown, however seems very long. Finally, considering all aspects, a product connection is deemed unlikely.