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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6650

2. Registrant Information.

Registrant Reference Number: 2016KP196

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

04-JUL-16

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. 11556-142

Product Name: k9 advantix II medium dog

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 03-Jul-2016, a 12 year old, 20 pound, neutered, male,Spaniel (Cocker) crossbred canine, in unknown condition,with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Medium 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

Cocker Spaniel crossbreed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

20

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

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • Renal System
    • Symptom - Polyuria
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Pain
    • Symptom - Other
    • Specify - Multi-organ failure

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

On 04Jul2016 the dog developed lethargy, diarrhea, polyuria, vomiting, ataxia, and sternoabdominal recumbency. On 06Jul2016 the dog was examined by a veterinarian and upon exam the veterinarian concluded that the dog was in pain with unspecified organ failure. It is unknown if treatements were performed and no necropsy was performed. The dog died.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Digestive disorders and lethargy are very unspecific signs and no oral route was reported. Even though more expected after oral uptake, Permethrin has the potential to cause slight neurological disorders (e.g. ataxia) in particular susceptible animals. However reported polyuria, sternoabdominal recumbency and further death are not expected after product application as signs are inconsitent with pharmaco-toxiclogical product profile. All reported signs likely associated to reported organ failure suspected by the vet. Even though time to onset is consistent for initial signs, considering long time to onset (3 days) for further course and unexpected signs, and another cause has been suspected a product connection is unassessable.