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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3254

2. Registrant Information.

Registrant Reference Number: 2013AM159

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

Address: 77 Belfield Rd

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.

13-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

26-NOV-11

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. 11556-150

Product Name: Advantage II kitten

  • 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.

.23

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).

One vial of Advantage II kitten was applied topically by the owner to one spot on the dorsal midline.

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

domestic shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.23

7. Weight (provide a range if necessary )

3

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

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 - Hesitancy to move
    • Specify - not moving
  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - lateral
  • Eye
    • Symptom - Tearing
    • Symptom - Watery eye
  • Respiratory System
    • Symptom - Other
    • Specify - liquid from nose
  • Gastrointestinal System
    • Symptom - Other
    • Specify - liquid from mouth
  • General
    • Symptom - Lethargy
    • Symptom - Other
    • Specify - stopped purring

12. How long did the symptoms last?

Persisted until death

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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

On 25Nov2011 owner applied Advantage II Kitten to Tabby a 12 week old female domestic shorthair feline that weighs 3.2 pounds at approximately 6 p.m. This product was recommended by the veterinarian because of flea infestation. Approximately 2 hours after application this feline stopped purring which is not normal. On 26Nov2011 this feline was lethargic all day. On 27Nov2011 at 7 a.m. this feline was lateral and not moving. The owner tried to give this feline water with an eye dropper and this feline would not take any. At approximately 8 a.m. this feline started having large amounts of clear liquid coming from her tear ducts, eyes, nose and mouth. This feline passed away about 10 a.m. The weigh of the kitten was now 3 pounds. No veterinary examination or necropsy was preformed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The reported clinical signs and fatal outcome are inconsistent with the toxicological product profile. No allergic or anaphylactic reaction reported. Oral ingestion of product was not observed. Even with oral product exposure which was not witnessed- signs would not be expected. Signs are more in line with an infectious disease. Hence, a connection with the product was considered unlikely.