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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2190

2. Registrant Information.

Registrant Reference Number: 29019

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.

14-MAY-19

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

04-MAY-19

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II medium dog

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

7. b) Type of formulation.

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 3-May-2019, a 5 year old, 11.2 kg, female spayed Cocker Spaniel in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 1.0 ML MED DOG, (-), by Veterinarian. The product was used according to label (No- dose too low)

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Cocker Spaniel

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

11.2

kg

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

  • Gastrointestinal System
    • Symptom - Drooling
  • Respiratory System
    • Symptom - Panting
  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Specify - Frantic
  • General
    • Symptom - Discomfort
  • Gastrointestinal System
    • Symptom - Vomiting
  • Skin
    • Symptom - Dermatitis
    • Symptom - Red skin
    • Symptom - Lesion
    • Specify - scabbing

12. How long did the symptoms last?

Unknown / Inconnu

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

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

The dog was administered diphenhydramine as it had experienced an undisclosed skin reaction when using this medication previously. On 4 May 2019 the dog was seen by the veterinarian as it was drooling, panting, frantic, uncomfortable, and vomiting. The dog developed a localized skin reaction of focal dermatitis including scabbing and redness. The dog was prescibed apoquel (Janus kinase inhibitor). On an unknown date the dog was seen by another veterinarian who clipped and cleaned the area, then prescibed apoquel (Janus kinase inhibitor), prednisone, and Viaderm (topical antibiotic). The outcome is unknown.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here