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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-5208

2. Registrant Information.

Registrant Reference Number: 2012TH158

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.

29-OCT-12

5. Location of incident.

Country: CANADA

Prov / State: PRINCE EDWARD ISLAND

6. Date incident was first observed.

06-JUL-12

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. Unknown

Product Name: K9 advantix

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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

Product Name: Sentinel

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

35.8

kg

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Vomiting
  • Renal System
    • Symptom - Lack of control of urination
    • Symptom - Other
    • Specify - pyelonephritis
    • Symptom - Other
    • Specify - low specific gravity

12. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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?

2

Day(s) / Jour(s)

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

Owner started using sentinel (orally) and K9 advantix(topically) monthly beginning early June 2012. July 6 owner called clinic to report that owner found dog lying in the road. It vomited green bile and was ataxic. The dog was observed eating charcoal briquettes earlier that day and may have been hit by a car. The dog had recovered by July 7 with just subq fluids and charcodote. Aug 16 owners reported Molly had a seizure and may have eaten some bounce sheets and dead wasps that had been sprayed with pyrethrins. The dog was given diazepam and started on phenobarb. Aug 21 the owner called and reported dog has fluid leaking from her hind end when she is lying down. Urinary incontinence was suspected, a urinalysis showed a specific gravity of 1.002. Dog was treated for pyonephritis with Baytril beginning Aug 29 2012. Dog responded to Baytril and was no longer leaking and sp. grav improved to 1.020. Phenobarb was discontinued at this time. Sept 20 2012 owner called clinic to ask the clinic to check her dog for toxins as she feels advantix and/ or sentinel is responsible for her dog's illness.


To be determined by Registrant

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

Major

19. Provide supplemental information here

This was only reported by the clinic at the owner's request. The clinic does not feel the illnesses and product use are related.