Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0691

2. Registrant Information.

Registrant Reference Number: 2013CK132

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

15-JUN-13

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

10-JUN-13

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage (unknown size)

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 10-Jun-2013, a 16 year old, 7.50 pound, neutered, male, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (non - US Registered Product) (Imidacloprid) once topically by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Short Hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

7.5

lbs

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

• Eye
  • Symptom - Glazed eye

• Nervous and Muscular Systems
  • Symptom - Shaking

• General
  • Symptom - Vocalizing

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Constipation

• General
  • Symptom - Neoplasia

• Blood
  • Symptom - Leukocytosis

• Renal System
  • Symptom - Renal failure
  • Specify - renal insufficiency

12. How long did the symptoms last?

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

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

Euthanised / Euthanasie

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

Approximately 4.5 hours later, the patient vomited twice and was straining to deficate. At the time of this communication, the clinical signs had not resolved. Further Info, June 17: cat was taken to veterinary clinic on June 16; had an abdominal mass that was suspected to be cancerous, had kidney insufficiency and high WBC count. Cat was euthanized.

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To be determined by Registrant

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

Major

19. Provide supplemental information here

Intended direct topical dermal exposure of the product to the cat. Digestive disorders, a palpable mass and renal disorders are unlikely product-related as inconsistent with the pharmacological and toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg / kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Owner choose for euthanasia of this geriatric cat due to medical condition the cat was in. Although short onset time, signs not expected and rather related to described underlying conditions and merely coincidental events. A relation to the product is therefore to be excluded.