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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4358

2. Registrant Information.

Registrant Reference Number: 2018RB060

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.

23-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-MAY-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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII large dog

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2,5

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 May 22, 2018 the pet owner applied K9 Advantix II large to their 9.4 kg, female neutered, 6 year old Maltese dog.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

9.4

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Respiratory System
    • Symptom - Panting
  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Symptom - Restlessness
  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Abnormal behaviour
  • Skin
    • Symptom - Irritated skin
    • Symptom - Red skin
  • Gastrointestinal System
    • Symptom - Gagging

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

The dog does not meet the minimum label requirement for this product dose. 2 hours later on May 22 the dog was panting, agitated, rolling and trying to rub the application site. The dog was also gagging. The pet owner bathed the dog and applied vitamin E. The application site was pink and irritated May 23, 2018.


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 rubbing at application site, agitation and rolling may reflect paresthesia caused by permethrin. Panting is not expected, might be a consequence of reported agitation. Reported irritation and reddening at application site might reflect local dermal sensitivity to the product. Gagging is more expected after oral uptake than after dermal application of the product. However, an oral uptake cannot be excluded. Considering consistent time to onset, a product connection is deemed to be possible.