Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2059

2. Registrant Information.

Registrant Reference Number: 2011CP009US

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.

02-MAY-11

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

11-JAN-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. 11556-118

Product Name: advatage 18

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %

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).

one tube was applied to a cat

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

domestic

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

11

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Respiratory System
    • Symptom - Dyspnea
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Twenty four hours after product application (11Jan11) the cat was deceased. The owner reports the cat had dyspnea shortly before death. DVM feels death was most likely due to a heart condition


To be determined by Registrant

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

Death

19. Provide supplemental information here

Sudden death is not an anticipated reaction with appropriate topical product administration. If any, typical adverse events such as behavioural disorders or skin reactions would be seen shortly after application. Systemic reactions are not expected with spot-on application. In case of product ingestion, signs such as salivation, vomiting or lethargy would be seen. Most likely, the cat`s death is entirely unrelated with product use. Two other cats of the same owner died 24 hours after product administration on different dates. This is very uncommon as product was used in the past without adverse signs in all affected cats. For all cats, the DVM suspected an underlying heart condition however other medical problems have to be considered as well in these geriatric cats. No necropsy was performed to clarify the cause of death.