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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6880

2. Registrant Information.

Registrant Reference Number: 2018RB171

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.

24-SEP-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-SEP-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. 27581      PMRA Submission No.       EPA Registration No.

Product Name: advantageII small dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 13-Sep-2018, an 11 year old, 4 pound, neutered, female, Japanese Chin canine, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of Advantage II Small Dog (Imidacloprid-Pyriproxyfen) topically by the owner.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Japanese Chin

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

1.81

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

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Runny nose
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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 14-Sep-2018, the dog exhibited lethargy, nasal discharge, shivering, ataxia and vomited twice. The vomiting resolved in approximately 10 minutes. The dog was not examined by a veterinarian and the clinical signs continued. Please note that the adverse reaction occurred September 14, 2018 approximately 18 hours post application of Advantage II. The dog was bathed and recovered within 2 hours.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

O - Unclassifiable/unassessable Vomiting is an unspecific and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. Lethargy is unspecific as well and may be associated with vomiting. Reported nasal discharge is not expected and may have numerous other causes. Neurological disorders are not expected with appropriate topical product use. Other causes must be considered. Though time to onset is consistent, considering all aspects, a product relation is unassessable.