Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2066

2. Registrant Information.

Registrant Reference Number: 2015KP023

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

Address: 2920 Matheson Blvd. East

City: Mississauga

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.

17-APR-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

24-JAN-15

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. 11556-151

Product Name: Advantage II Small Cat

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 18-Jan-2015, a 13 year old, 6.5 pound, neutered, male, Domestic Shorthair feline, in fair condition, with hyperthyroidism and fleas, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner.

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

Other

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 )

13

7. Weight (provide a range if necessary )

6.5

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Anorexia

• Renal System
  • Symptom - Inappropriate urination

• Gastrointestinal System
  • Symptom - Inappropriate defecation

• General
  • Symptom - Vocalizing

• Respiratory System
  • Symptom - Panting

12. How long did the symptoms last?

Unknown / Inconnu

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 24-Jan-2015, the cat exhibited ataxia, decreased appetite, inappropriate urination, inappropriate defecation, vocalization, panting and death. No treatments or diagnostics were performed. No necropsy was performed. No more information is expected. The case is closed.

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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

Note : Product was well tolerated on previous application