Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6156

2. Registrant Information.

Registrant Reference Number: 2015KP272

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Bvd. East

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

19-OCT-15

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. Unknown

Product Name: k9 advantix (unknown)

• 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).

On an unknown date in approximately 2011, a 10 year old, female, Dachshund canine, in fair condition, with no known concomitant medical conditions, was administered 1 tube of an unspecified size of K9 Advantix (Imidacloprid - Permethrin) topically by the owner.On an unknown date in 2011, the dog was switched to a monthly regimn of K9 Advantix II Medium Dog (imidaclopridpermethrin- pyriproxyfen). The product was applied monthly with the last dose being on an unknown date in 2014.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Dachshund (Standard)

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

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

• Renal System
  • Symptom - Other
  • Specify - Renal Disorder

• Blood
  • Symptom - Anemia

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Intervertebral disk disease

• General
  • Symptom - Neoplasia

• Cardiovascular System
  • Symptom - Other
  • Specify - Cardiac Disorder
  • Symptom - Other
  • Specify - Cardiac Failure

• Gastrointestinal System
  • Symptom - Other
  • Specify - Dental Disease

12. How long did the symptoms last?

Unknown / Inconnu

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

On an unspecified date in 2014, the dog developed chronic renal disease, immune mediated hemolytic anemia, ruptured 2 discs, developed a mass on her back (which was removed surgically), was found that her heart was too small, she developed congestive heart failure, and dental disease. The dog was seen by a veterinarian for these clinical signs on unspecified dates. It is not know what treatments were performed. The dog passed away on 24Apr2015, when she was 14 years old. No necropsy was performed. No more information expected. Case closed. Note from LDSM: The reporting party did not call to report the death of this animal but to inquire about use on another animal. Note: Previous application was well tolerated.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported signs are not expected as they are inconsistent with the pharmaco-toxicological product profile. Time to onset was exceptionally long (approx. 4 years) due to the fact that the reporting party did not call to report the death of this animal but to inquire about use on another animal. Other causes are more probable. Considering all aspects, a product relation is considered to be unlikely.