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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6622

2. Registrant Information.

Registrant Reference Number: 2016KP168

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

10-JUL-15

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.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-152

Product Name: advantage II large cat

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9,1 %
    • PYRIPROXYFEN
      • Guarantee/concentration ,46 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

,8

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 10-Jul-2016, a 7 year old, 13 pound, neutered, female,Maine Coon Cat feline, in good condition, with no concomitant medical conditions was administered 1 tube of Advantage II Large 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

13

lbs

8. Route(s) of exposure

Skin

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

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
    • Symptom - Vocalizing

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 6 hours post application, the cat exhibited vocalization and marked lethargy. On 11-Jul-2016, the cat was found deceased. No necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Vocalisation and lethargy may be a behavioural response to the product sensation or to the product smell is expected. However, death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Product has wide margin of safety. No signs of allergy/anaphylactic reaction reported. However, considering short time to onset, absence of necropsy and unknown circumstances of death, product relation is deemed unassessable.