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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4028

2. Registrant Information.

Registrant Reference Number: 2015KP145

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

Address: 2920 Matheson Blvd. East

City: Toronto

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.

20-JUL-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. 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 an unknown date in 2014, a male, Unknown Breed 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

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
  • Gastrointestinal System
    • Symptom - Diarrhea

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

An unspecified date in 2014, post product administration the dog developed diarrhea. On an unknown date in 2014 the dog passed away. No necropsy was performed. No more information is expected. Case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Note: The intent on the call to BAH was not to report the death of this patient but to inquire about an expiration date. Diarrhoea is unspecific in dogs and may have multiple potential causes. Potential oral uptake was not reported and no other digestive disorders which may reflect oral uptake, e.g. hypersalivation or vomiting, have been reported. Death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, medical history and time to onset unknown - necropsy not available) as the intent of the phone call to Bayer was to inquire about an expiration date, and not to report the death of the patient. No signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Thus other etiologies more probable. Considering all aspects, product connection deemed to be unlikely.