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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1061

2. Registrant Information.

Registrant Reference Number: 2018RB001

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.

11-JAN-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-OCT-17

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. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Cat

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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 October 16, November 16, and December 16, 2017 a 5.1 kg, 13 year old cat with hyperthyroidism was treated for fleas with the application of Advantage II large cat.

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

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

5.1

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 - Vomiting
  • Skin
    • Symptom - Lesion

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

Within 24 of hours of application on two occasions the cat vomited and recovered within 24 hours. An unknown time after the application of Advantage II large cat December 17, 2017 the cat developed a red, raised circular skin lesion that was not at the direct application site. The veterinarian clipped and assessed the area but no treatment was performed and thus this case is classified as minor.The outcome is unknown.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

O - Unclassifiable/unassessable Vomiting is an unspecific sign and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. However, short time to onset and thus a reaction to accidentally ingested product cannot be excluded. Skin lesions on other than the application site are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Time to onset consistent for initially reported vomiting, however inconsistent for skin lesion. Overall, a product involvement is unassessable.