Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5803

2. Registrant Information.

Registrant Reference Number: 2018EB215

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-AUG-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-AUG-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: advantageII 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).

The patient is a 1.5 year old 4.1 kg male neutered domestic long hair cat. The patient had fleas. This cat is an indoor outdoor cat who has not been seen by a veterinarian in the last year prior to application of the product. On August 16th the pet owner applied 1 vial of Advantage II large cat topically on the patient. This was the first time the patient was receiving Advantage II.

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

domestic long hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

4.1

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Panting
  • Symptom - Laboured breathing

• Skin
  • Symptom - Pale mucous membrane colour

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Collapse
  • Specify - Collapse NOS

12. How long did the symptoms last?

Persisted until death

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

Died

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 21st the patient had partial anorexia. On August 22nd the patient was very lethargic and went down hill during the day, by the evening the patient had abdominal breathing, panting and pale mucous membranes. The patient was brought to the emergency vet clinic at 1 am on August 23rd but crashed and died on the way in to the hospital. The outcome is death.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable - Reported partial anorexia, and lethargy are unspecific and may have various other causes. Reported panting, laboured breathing, pale mucous membrane and collapse are not expected with appropriate topical product. Outcome death not expected either. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Time to onset is long. Other causes should be considered (e.g. poisoning). No necropsy performed. Considering all aspects, a product relation is unassessable