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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6121

2. Registrant Information.

Registrant Reference Number: 2018RB132

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.

16-JUL-18

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

15-JUL-18

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: K9advantixII pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

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 15-Jul-2018, a 6 year old, 21 pound, neutered, male, Yorkshire Terrier/Bichon Frise crossbred canine, in unknown condition, with concomitant medical condition of anorexia, was administered 1 tube of K9 Advantix II (unspecified) (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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred (Yorkshire Terrier X Bichon Frise)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

9.52

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Abnormal behaviour
    • Symptom - Insomnia
    • Specify - Not sleeping
  • Skin
    • Symptom - Edema
    • Symptom - Erythema

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

Unknown/Inconnu

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 1 hour post application the canine vomited one time. Approximately 4 hours post application the canine had a generalized pruritus and was itching the application site and turning and looking at his back ( behavioral disorder NOS), and did not sleep, and had a swollen red foot. On approximately 16-Jul-2018, the canine with bathed with an unspecified shampoo and administered diphenhydramine and the clinical signs continued. The canine was not examined by a veterinarian and no treatments were performed.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

B - Possible Reported vomiting is more expected after oral uptake than after dermal application of the product. However, an inadvertent oral uptake cannot be excluded. Reported behavioural disorders are very unspecific and may have other causes. Pruritus is not expected to be generalised but rather be linked to the application site. However, this sign along with reported itching at the application site and reported behavioural disorders may be a consequence of the uncomfortable feeling caused by the applied product. Swollen red foot is not expected either and is likely a consequence of reported pruritus in this case. Considering consistent time to onset, a product connection is deemed to be possible.