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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4520

2. Registrant Information.

Registrant Reference Number: 2013TH142

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.


5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.


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.


PMRA Registration No. 27661      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 20

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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?


Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Min Schauzer

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms


  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Itchy skin
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
  • General
    • Symptom - Pain
  • Gastrointestinal System
    • Symptom - Other
    • Specify - abdomen feels tight
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • Skin
    • Symptom - Pruritus

12. How long did the symptoms last?

Unknown / Inconnu

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident


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

On approximately 10Jul2013, an 8.5 year old, 5.8 kg, spayed, female, Miniature Schnauzer canine, in good condition, with no known concomiitant medical conditions, was administered 1 tube of Advantix 4.6-11Kg once topically by the owner. On approximately 12Jul013 the patient became lethargic, began having difficulty walking, and developed pruritus. The owner is not sure if signs lasted 2-3 weeks or until the next applicaiton. The owner reapplied 1 tube of Advantix 4.6-11Kg on approximately 12Aug2013. On approxiamtely 14Aug2013 the patient became lame in both hind legs and her abdomen was seemingly tight. 16Aug2013 the patient was evaluated by a veterinarian and determined the patient's back to be painful (a displaced disc was suspected) and prescribed metacam. The patient was given a large overdose of metacam by accident. The patient was then started on intravenous fluids 17Aug2013 as a precaution. Blood work was also performed and the urea was found to be elevated. The patient was kept on the fluids until 20Aug2013 and then released. As of Aug 27 the pet owner feels the dog is more lethargic than usual and is not walking normally. The owner will take the dog to be seen by a veterinarian for a second opinion.

To be determined by Registrant

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


19. Provide supplemental information here