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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0703

2. Registrant Information.

Registrant Reference Number: 2017KP005

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.


Prov / State: UNKNOWN

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.       PMRA Submission No.       EPA Registration No. 11556-125

Product Name: advantage II medium dog

  • Active Ingredient(s)
      • Guarantee/concentration 9.1 %
      • Guarantee/concentration .46 %

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 04Jul2014, a 10 year old, 14 pound, intact, female,Pinscher (Miniature) canine, in unknown condition, with no known concomitant medical conditions, was administered 1tube of Advantage II Medium Dog (Imidacloprid-Pyriproxyfen) topically by the owner.

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


2. Type of animal affected

Dog / Chien

3. Breed

Miniature Pinscher

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

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

11. List all symptoms


  • General
    • Symptom - Death
  • Skin
    • Symptom - Pruritus
  • Cardiovascular System
    • Symptom - Other
    • Specify - Cardiac DIsorder

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 05Jul2014, the dog developed generalized pruritus. On 01Aug2014 the pruritus continued and the owner applied another tube of Advantage II Medium dog. Follow up received on 19th Oct 2016: On 01Aug2014, the pruritus continued and the product was re-applied. On an unknown date, in 2016, the dog was diagnosed with congestive heart failure and died. No known necropsy was performed. The communication was not to report this event, but to discuss a different dog in the household. No more information is expected. This case is closed.

To be determined by Registrant

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


19. Provide supplemental information here

Generalized pruritus is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Congestive heart failure is neither expected nor inline with products pharmaco-toxicological profile. Death is inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold over dosage tolerated by dogs without showing any side effect. The cause of death was a congestive heart failure. The product was reported to be used on the dog for a significant period of time with no issues. This is a geriatric animal. The communication was not to report this event, but to discuss a different dog in the household. Even though time to onset is short for pruritus, it is long for other signs. Finally, even though no necropsy was performed, Considering all aspects product relation is unlikely.