Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2191

2. Registrant Information.

Registrant Reference Number: 2017KP135

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

Address: 2920 matheson BLVD

City: Mississaugua

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-APR-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

10-FEB-17

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.

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 10Feb2017, an 8 year old, 32 pound, neutered, female,Terrier (Jack Russell) crossbred canine, in unknown condition, with no known concomitant medical conditions, 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

Jack Russell Terrier Crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

32

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

• Blood
  • Symptom - Anemia

• Gastrointestinal System
  • Symptom - Other
  • Specify - Decreased Bowel Movements

• Renal System
  • Symptom - Urine discoloration

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Jaundice

• Gastrointestinal System
  • Symptom - Weight loss

12. How long did the symptoms last?

Unknown / Inconnu

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

Approximately 8 hours post application, the canine exhibited lethargy, anorexia, and adipsia. On 13Feb2017, the canine exhibited a darker colored urine and minimal bowel movements, The canine was examined by a veterinarian; bloodwork showed a decreased red blood cell count and unspecified liver values, and she was jaundice. The vet administered unspecified injections and intravenous medications. On 19Feb2017, the canine, now 28 pounds, died. It is unknown if a 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

Reported lethargy, anorexia and adipsia are very unspecific signs and may have numerous causes. Later reported darker colored urine and minimal bowel movements, decreased red blood cell count, unspecified liver values, weight loss and jaundice. Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile, however is likely due to an underlying condition (e.g. liver disorder). Considering overall aspects, a product connection is unassessable.