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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-2676

2. Registrant Information.

Registrant Reference Number: 2012TH022

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.

19-APR-12

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

17-APR-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. 27659      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 100

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

7. b) Type of formulation.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Great Pyrenees X Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

44.5

kg

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

  • Skin
    • Symptom - Lesion
  • General
    • Symptom - Hyperactivity
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Bizarre behaviour
  • Respiratory System
    • Symptom - Panting
  • General
    • Symptom - Abnormal behaviour
    • Specify - running in circles
    • Symptom - Vocalizing
    • Specify - whining
  • Skin
    • Symptom - Erythema
    • Symptom - Hair loss
    • Specify - alopecia
    • Symptom - Dermatitis
    • Specify - crusting at the tail base and side of tail

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 used 1 application of advantix in 2011 with no reaction. Purchased this package from (name) pharmacy. Applied April 17 2012 and within 3 hours the dog was acting oddly (running in circles, whining). A bath was given and vitamin E was applied. The dog was examined at the veterinary college on April 24 as the dog still seemed lethargic, doesn't want to go for walks, increased panting and had mucousy loose stool 24 hours after application and had developed hot spots at two of the application sites per owner. The sites are on the right shoulder and left hip and seem unusual sites for application per the examining vet and show alopecia, erythema and crusting. The owner was also applying diatomaceous earth at the same time. Two other application sites seem fine. There is also alopecia, erythema and crusting at the tail base and side of tail where there was no product applied. Dog is overweight and hypothyroidism is suspect. The affected areas were clipped and cleaned. A skin scraping of the alopecic areas showed active pyoderma. Dog also swims in a lagoon 2-3 times a day. Cephalexin was dispensed.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Moderate as treatment was given