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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2014-2886

2. Registrant Information.

Registrant Reference Number: 2014CK174

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

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

19-JUN-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-JUN-14

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. 27661      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix 20

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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).

A cocker spaniel x poodle fs 6yr of unknown weight was treated with k9 advantix 20 on june 9th

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

cocker spaniel x poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

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

<=30 min / <=30 min

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Agitation

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

Following product application, the dog became itchy (generalized) immediately and the dog was agitated. The owner applied vitamin e oil and gave the dog diphenhydramine. the pruritus continued. the dog presented to the clinic for for diarrhea and vomiting on june 17th and was treated with metronidazole, probiotics and subcutaneous fluids. On june 18th the dog was recovered except for itchiness of the feet which continued for an unknown period of time.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Status update: Update with additional info from vet clinic: 6yr FS cockerpoo of unknown weight was treated with k9 advantix 20 on june 9th, 2014. Following product application on june 9th, the dog became itchy (generalized) immediately and the dog was agitated. The owner applied vitamin e oil and gave the dog diphenhydramine. the pruritus continued. the dog presented to the clinic for for diarrhea and vomiting on june 17th and was treated with metronidazole, probiotics and subcutaneous fluids. On june 18th the dog was recovered except for itchiness of the feet which continued for an unknown period of time.