Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3044

2. Registrant Information.

Registrant Reference Number: 2013AM114

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.

22-APR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-JAN-04

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. Unknown

Product Name: K9 Advantix (unknown size)

• 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.

Unknown

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 (unknown size) 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

Toy Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Lesion

12. How long did the symptoms last?

Persisted until death

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

Yes

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

One day after application the dog had a lesion at the application site. The dog was examined by a veterinarian and had an unknown ointment prescribed. On approximately 08Jun2004 the dog recovered. On an unknown date in Oct2011 the dog passed away from unknown causes. A necropsy was not performed

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Dermal reactions at the application site are possible with any topically applied product, however would not expect lesion development directly related to product. But it is likely that the dog scratched at the site and caused skin lesions by selftrauma. Considering sign location and consistent time to onset, a product connection is deemed to be possible. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Long onset time of approx. 7 years allows product exclusion. Other etiologies are more probable, e.g. underlying cardiac disorders. Considering long onset time, product involvement on dog's death was considered unlikely and case was assessed with "N".