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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6028

2. Registrant Information.

Registrant Reference Number: 2010CP

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.

18-OCT-10

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

22-AUG-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. 25127      PMRA Submission No.       EPA Registration No.

Product Name: advantage 55

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

Units: %

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).

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

Dog / Chien

3. Breed

australian shepherd

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.2

7. Weight (provide a range if necessary )

Unknown

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • General
    • Symptom - Listless
  • Blood
    • Symptom - Abnormal coagulation
    • Specify - DIC
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

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

Dr called to report that an owner applied Advantage55 to her dog on Saturday 21Aug10. The following day, the dog vomited, did not want to eat, and had soft stools. The dog presented in clinic on 23Aug10 with the same signs; attending DVM thought the dog looked listeless; hydration was good. DVM treated with an injection of Cerenia and sent home Amprol tablets. On 24Aug10, the dog presented in clinic with vomiting and anorexia. Xrays are pending. DVM hasn't ever seen a reaction like this to Advantage and doesn't believe it to be product related. Follow-up: Owner called VTS to report dog died on 31 Aug 2010. She reports necropsy revealed DIC.


To be determined by Registrant

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

Death

19. Provide supplemental information here

DIC and death are not anticipated with appropriate topical product administration as non-consistent with the product`s pharmacological profile nor is chronology consistent. Product administration and onset of signs were deemed to be coincidental.