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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6164

2. Registrant Information.

Registrant Reference Number: 2010CP055US

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.

01-JUL-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. 27659      PMRA Submission No.       EPA Registration No.

Product Name: K9advantix 100

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %

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).

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

Dog / Chien

3. Breed

dalmatian

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

8

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Bloating
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • Gastrointestinal System
    • Symptom - Bloody diarrhea
  • General
    • Symptom - Death

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

Owner applied the k9-100 for the first time on July 01 2010 to the dog. Approx 1 hour after the application the dog was hypersalivating, seemed bloated and seemed restless. No treatments have been done and the dog has not been seen by the dvm. Follow-up: 7/9/10 - Called owner for follow up information. The owner said that the hypersalivation and the restlesness went away on 7/1/10, however the bloat never went away. On 7/7/10 the dog had bloody diarrhea and on 7/8/10 the owners woke up to find that the dog had passed away. The dog was taken to the dvm on 7/8/10 where a necropsy was done and it was determinded that the dog had passed away because of Gastric Dilatation Volvulus.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Salivation and restlessness may have been transient signs of a distaste reaction. These signs resolved shortly after onset. However the bloating, bloody diarrhoea and subsequent death were likely caused by the volvulus.