Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0520

2. Registrant Information.

Registrant Reference Number: 2015CK028

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.

19-JAN-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

29-OCT-14

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. 11556-143

Product Name: k9 advantix II large dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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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 20-Oct-2014, a 2 year old, 55 pound, intact, female, Labrador Retriever/Golden Retreiver crossbred canine, in good condition, with no known concomitant medical conditions, had a ovariohysterectomy.On 29-Oct-2014, the dog was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

55

lbs

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Polydipsia

• Blood
  • Symptom - Bleeding

• Respiratory System
  • Symptom - Respiratory distress

• Skin
  • Symptom - Bruises
  • Specify - subcutaneous and intramuscular bruise at 8 and 9 intercostal spaces

• Gastrointestinal System
  • Symptom - Other
  • Specify - hemoabdomen - hemorrhage NOS

• Reproductive System
  • Symptom - Other
  • Specify - uterian stump hemorrhage

• Respiratory System
  • Symptom - Other
  • Specify - diaphragmatic hemorrhage
  • Symptom - Other
  • Specify - hemothorax

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?

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

Approximately 3 hours post application, the dog had respiratory distress, ataxia, polydipsia, and vomited once.Approximately 7 hours post application, the dog died, CPR was performed with no positive results.On approximately 03-Nov-2014, the necropsy revealed a subcutanous and intramuscular bruise at the 8 and 9 intercostal spaces (ecchymosis), hemoabdomen (hemorrhage NOS) secondary to uterian stump hemorrhage ,diaphragmatic hemorrhage and hemothorax. The preliminary cause of death is fatal internal hemorrhage. Microscopic tissue evaluation revealed cardiac hypoxia and segmental hypertrophic arteriosclerosis of intramural coronary arteries. Cause of death was determined to be severe, subacute, abdominal hemorrhage originating from urterine arteries

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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

Vomiting and ataxia more expected after oral product exposure than after topical product application. Potential oral uptake is not witnessed. Respiratory distress and polydipsia are not expected either. Signs may have many potential other causes. Death with reported necropsy findings is unexpected and rather inconsistent with pharmacotoxicological product profile. The dog was operated for ovariohysterectomy 9 days prior to application of product and thus as reported, death was due to severe, subacute, abdominal hemorrhage originating from urterine arteries. Though consistent time to onset, considering all aspects, a product connection remains unlikely.