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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1437

2. Registrant Information.

Registrant Reference Number: 2013AM023- US0009781

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.

01-OCT-10

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-OCT-10

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)

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

Product Name: Advantage 18

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

7. b) Type of formulation.

Liquid

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 approximately 01-Oct-2010, a 10 year old, 11 pound, spayed, female, domestic medium hair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage 18 Topical Solution (Imidacloprid) once 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

DMH

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

11

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively
  • General
    • Symptom - Abnormal behaviour
    • Specify - licking lips

12. How long did the symptoms last?

<=30 min / <=30 min

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

Immediately after application, the patient began licking her lips (behavioral) and was agitated. Those symptoms resolved approximately 5 minutes later. On 01-Oct-2011, the patient died.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here