Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8134

2. Registrant Information.

Registrant Reference Number: 2017CP339

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.

04-OCT-17

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

04-AUG-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)

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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).

A 4.8 kg, 9 year old feline male neutered DMH with a flea infestation, was applied one tube AdvantageII large cat once topically by the veterinarian

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 Medium Hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

4.8

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

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Difficulty Breathing

• Eye
  • Symptom - Pupil dilation

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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 August 04 2017, a 4.8 kg, 9 year old feline male neutered DMH with a flea infestation, was applied one tube advantageII large cat once topically by the veterinarian; a few hours later, cat had decreased activity , had difficulty breathing and had dilated pupils; reaction lasted 3 days.

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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 decreased activity may be a behavioural response to the product sensation. Breathing difficulty is not expected with appropriate topical product use and may rather be a behavioural reaction to product sensation than a sign of respiratory illness. Dilated pupils are not expected with appropriate topical product use. No oral product exposure witnessed. However, a connection with accidentally ingested product cannot be ruled out entirely. Considering consistent time to onset, a product relation is possible.