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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0010

2. Registrant Information.

Registrant Reference Number: 2018BS051

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-OCT-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-OCT-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. 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 17 October 2018, 1 tube of advantage II Large Cat was applied to a Siamese, M/N, 5.8 kg feline.

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

Cat / Chat

3. Breed

Siamese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

5.8

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

  • Skin
    • Symptom - Hair loss
    • Symptom - Erythema

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

24 hours later on 18 October 2018 the owner noticed alopecia at the application site at the base of the neck. 36 hours later on 19 October 2018 the owner saw erythema at base of neck and what looked like a chemical at base of neck and between toes of left hind foot. The feline was examined by veterinarian on 19 October 2018 and was instructed to keep affected area clean and apply antibiotic ointment; Condition is ongoing but has improved. Has previously used advantage 18 with not issues. This was advantage II large cat use the first time and reacted.


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 Reported application site disorders are dermal reaction at the application site in a particular sensitive animal. Time to onset is consistent. Erythema 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 is not consistent. Overall, a product involvement is unassessable.