Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4735

2. Registrant Information.

Registrant Reference Number: 2018TH044

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.

06-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

16-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)

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PMRA Registration No. 27586      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Large Cat

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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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 May 16 2018 a pet owner applied one tube of advantage II large cat to a 7 yr old 7 kg MN DSH.

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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

7

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 - Lesion
  • Specify - Application site scab
  • Symptom - Dermatitis
  • Specify - Application site crust
  • Symptom - Hair loss
  • Symptom - Itchy skin

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Lesion
  • Specify - Skin sore

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

Within one day the cat had application site itching. On exam May 29 the vet noted application site scabs, alopeica and crusting, scabs on face, mild pruritis. The cat was lethargic and had sores on his face and neck. Bloodwork was performed. The cat was bathed and treated with convenia and vanectyl P. The cat has a pre-existing systolic murmur.

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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 In individual cases, dermal reactions at the application site are possible in animals that are particular sensitive. Generalized skin reactions or skin reactions on other than the application site are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Lethargy is an unspecific sign and may have various other causes. In this case it is associated with other reported signs. Time to onset is short for application site, however it is long for other signs. Considering all aspects, product relation is unassessable.