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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4220

2. Registrant Information.

Registrant Reference Number: 2016KP124

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-JUL-16

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. 11556-144

Product Name: k9 advantix II extra large 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.

4

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 Jun-2013, a 5 year old, 77 pound,neutered, male, Retriever (Flat-Coat) canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra 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

Flat-coated Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

77

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Behavioural Disorder

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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 an unspecified date in Jun2013 the dog had unspecified behavioral changes and was anorexic. The dog was examined by a veterinarian and started on an unknown treatment. The dog was also syringe fed by the owner. On an unspecified date in Jun2013 the dog died. No necropsy was performed. No more information expected. This case is closed. Note from LDSM: The communication was not to report this event, but to discuss the use of another product on a different animal. Note: Previous applications 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 behavioural disorder and anorexia are very unspecific signs and may have multiple potential causes in a dog. Reported death is not expected after product application, as it is inconsistent with pharmacotoxicological product profile. Death likely linked to an underlying condition, however no serious signs had been reported. Even though time to onset unknown, occurrence of death within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Moreover, previous applications were well tolerated. Other etiologies more probable. Actually, the intent of the call was not to report this event, but to discuss the use of another product on a different animal. Finally, though no necropsy was performed and time to onset is unknown, considering the known product profile, sufficient information exists to conclude that the product did not cause the event and a product connection is deemed to be unlikely.