Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6393

2. Registrant Information.

Registrant Reference Number: 2013CK059

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.

30-AUG-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-144

Product Name: K9 Advantix 100

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

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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 30-Aug-2013, a 15 year old, 8.00 pound, spayed, female, Domestic Shorthair feline, in good condition with no known concomitant medical conditions, was administered an unknown dose of K9 Advantix 100 (Imidacloprid - Permethrin) once topically by the owner. This is an off-label use of the product as it is not labeled for use on cats.

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

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Vocalizing
  • Symptom - Abnormal behaviour

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

Approximately 3 hours post product application the feline was vocalizing, had application site pruritus, and was walking in the area of the house where the other cats frequented that she usually avoided (behavioral). The owner let the feline outside. On 31Aug2013 the owner found the feline outside dead. No necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Behavioural disorders and application site pruritus may reflect discomfort caused by the applied product. Even though permethrin is toxic for cats and may have a fatal outcome, generally cats have a good chance to recover if adequate treatment is applied in time. No sign of permethrin toxicosis reported. Other causes are more probable. Cat was elderly. No necropsy available. Even though consistent time to onset, a product connection is deemed to be unassessable.