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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0686

2. Registrant Information.

Registrant Reference Number: 2017KP008

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. 11556-151

Product Name: advantage II small cat

  • 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 an unspecified date in Jul 2014, a 14 year old,approximately 17.5 pound, neutered, male, Ragdoll crossbred feline, in good condition, with concomitant lethargy,was administered 1 tube of Advantage II Small Cat(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

Cat / Chat

3. Breed

Ragdoll Crossbreed

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

<=30 min / <=30 min

11. List all symptoms


  • General
    • Symptom - Lethargy
    • Symptom - Death
    • Symptom - Vocalizing
    • Symptom - Abnormal behaviour

12. How long did the symptoms last?

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

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

Immediately post administration, the feline exhibited lethargy. Approximately 36 hours post administration in Jul 2014, the lethargy resolved. On an unknown date post administration in Jul 2014, the feline began groaning and moaning (vocalization). The feline was taken to the veterinarian for an examination and during the car ride, the cat did not exhibited his normal behavior while riding in a car (behavioral nos). The feline was hospitalized and died overnight. Diagnostics and treatments are unknown and no known necropsy was performed. No further information is expected. This case is closed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss product use on a stray cat and was not to specifically report the death of the patient.

To be determined by Registrant

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


19. Provide supplemental information here

Initially reported lethargy is an unspecific sign and may have multiple potential other causes in an animal, it may represent a behavioural response to the product sensation. Time to onset is short. Moreover, the animal involved in this case had concomitant history of lethargy which may have contributed to the sign. Later reported vocalization and behavioural disorder are unspecific signs and may have various other causes. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Animal involved in this case was geriatric. In case of suspected product involvement event would have been reported in close proximity and not long time (almost 2 years) after. The reason for the initial call was to discuss product use on a stray cat and not to report the death of the patient. Even though some information is not available (exact time to onset for death and necropsy report), considering available information a product relation is unlikely.