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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2070

2. Registrant Information.

Registrant Reference Number: 2011TH009

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Road

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


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. 25127      PMRA Submission No.       EPA Registration No.

Product Name: advantage 55

  • 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).

Product was applied Nov 1 by clinic staff with no concerns. Product was applied Nov 17 and the dog may have had a reaction to the product. Product was applied again Nov 30 with no concerns. Product was applied for treatment of lice, which is extra-label in Canada. Advantage is however safe for use and efficacious when used to treat lice.

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


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?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms


  • Gastrointestinal System
    • Symptom - Gagging
  • Skin
    • Symptom - Hives
  • Eye
    • Symptom - Swollen eye

12. How long did the symptoms last?

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

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

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

Dog was seen for rodenticide ingestion Nov 1 2010. Vit K was prescribed as was advantage as the animal was noted to have lice on exam. It appears the advantage was applied in clinic by clinic staff and was tolerated well. Nov 17 the owner applied another dose (at 2 week interval even though Dr prescribed at 3 week intervals). Nov 18 the owner contacted clinic as the dog started dry heaving and gagging after advantage application on Nov 17. The owner washed the dog right away. Later that night, after receiving oral vit K for ongoing treatment for rodenticide therapy, the owner noticed the dog's left eyelid was puffy. The morning of the 18th the right eyelid was also swollen. The owner gave benadryl and the swelling decreased. The dog was examined and uriticarial lesions were noted on the shoulders, thorax and abdomen. The owner continued to give benadryl along with each dose of vitamin K and the dog was reported to be normal by Nov 22. Nov 30 advantage was applied in hospital with no adverse reactions.

To be determined by Registrant

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


19. Provide supplemental information here

Classed as moderate as benadryl was given.