Health Canada
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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3624

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0035371 (Report 577314)

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.

28-JUN-19

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. Unknown

Product Name: K9 Advantix pipette size unknown

  • Active Ingredient(s)
    • Imidacloprid
      • Guarantee/concentration 8.8 %
    • Permethrin
      • Guarantee/concentration 44 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 2004, a Retriever (Labrador, Black) canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix (unspecified) (Imidacloprid - Permethrin) 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Unknown

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Liver
    • Symptom - Other
    • Specify - unspecified liver disorder
  • General
    • Symptom - Parasitism
    • Specify - Lyme disease
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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

On an unknown date in 2004, the canine was examined by a veterinarian, diagnosed with Lyme disease, and had a liver disorder. The canine died and no known necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Lyme disease is not expected after product application. No ticks were reported and thus it is unclear when the dog contracted the Lyme disease. Moreover borrelisis has a long incubation period (1-5 months), therefore the animal could have contracted the disease before product application. Reported liver disorder and death are not expected after product application as it is inconsistent with the pharmaco-toxicological profile of the product. Signs may be related with reported Lyme's. Further, reliability of the report is questionable, due to very low level of information. In case of suspected product involvement, adverse event would have been reported in close proximity of the event and not 15 years after. Considering all aspects, even though time to onset is unknown, a product connection is deemed unlikely.