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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1062

2. Registrant Information.

Registrant Reference Number: 2018RB002

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

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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. 27584      PMRA Submission No.       EPA Registration No.

Product Name: advantage II extra large dog

  • 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).

On January 8, 2018 the pet owner administered Advantage II extra large dog to their 7.5 year old, 46.8 kg, male neutered boxer dog who had fleas.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Boxer (German Boxer)

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 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms


  • Skin
    • Symptom - Burning skin
    • Symptom - Lesion
  • Respiratory System
    • Symptom - Panting

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

Approximately 5-6 hours after application the dog developed a burn around his mouth. The pet owner suspects the dog came in contact with the product near his mouth. The area is healing but he has not fully recovered at this time. Note. Additional information from Duplicate case CAN-BAYERBAH-2018-CA0000001 (Report 466798): On 08-Jan-2018, a 7.5 year old, 105 pound, neutered, male, Boxer canine, in unknown condition, with concomitant medical conditions of fleas and pruritus, was administered 1 tube of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) topically by the owner. Approximately 6 hours post application, the dog exhibited a skin lesion just below the nose and panting. The dog was not examined by a veterinarian and the clinical sign continued. Product was Advantage II XL

To be determined by Registrant

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


19. Provide supplemental information here

B - Possible Skin reactions on other than the application site are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Panting is not expected with appropriate topical product use and may rather be a behavioural reaction to product sensation than a sign of respiratory illness. Considering short time to onset, a product relation is considered possible.