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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6165

2. Registrant Information.

Registrant Reference Number: 2010CP056US

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.

14-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. 27658      PMRA Submission No.       EPA Registration No.

Product Name: K9advantix10

  • 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

miniature poodle

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • Renal System
    • Symptom - Renal failure
  • General
    • Symptom - Death

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?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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 reports product was applied to two dogs on 14 Jul 2010. Dogs stopped eating and developed diarrhea that evening. Owner suspects dogs were grooming application site that day, though no oral exposure to product was actually witnessed. On 15 Jul, boths dogs developed intermittent vomiting. Owner reports that she has repeatedly provided food to dogs, and that they vomit each time they eat. Owner is unclear as to timeframe of resolution of inappetance, and states that dogs have remained inappetant though she also reports that dogs eat food immediately prior to emesis. Owner has bathed dogs with oatmeal-based shampoo but signs have persisted. Dogs went to veterinary clinic on July 21. DVM reports both dogs presented to clinic with vomiting and diarrhea. DVM hospitalized dogs and placed both dogs on IVF; no further treatment had been initiated and no diagnostics were conducted on Brandi, Pepe's bloodwork revealed kidney failure;. Pepe arrested shortly after initiation of treatment and died at that time. Brandi was hospitalized and IV fluids were administered all day. She then died at home after being discharged on the evening of 21 Jul. DVM states cause of dealth cannot be ascertained. No necropsies done.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Observed gastro-intestinal signs are rather unspecific in dogs and may have multiple potential causes besides various intoxications, like bacterial and viral infections. Kidney failure is not in line with pharmaco-toxicological product profile, but may have developed secondarily after excessive loss of body fluids. Death is not expected following topical application of product.