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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6106

2. Registrant Information.

Registrant Reference Number: 2014CK403

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.

20-OCT-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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. 11556-128

Product Name: Advantage I0

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 2010, a 10 year old, female, Yorkshire Terrier canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage 9 Topical Solution (Imidacloprid) topically by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

yorkshire terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

Unknown

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 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Neoplasia

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

On an unspecified date, approximately 3 months post application, the dog was diagnosed with neoplasia and died. It is not known whether or not a necropsy was performed.. The reason for the initial phone call was to discuss the expiration date of the product and not to report the death of the patient.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported signs (such as neoplasia and death) are not expected after topical application of the product. These signs are inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety and no carcinogenic potential. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Dog was geriatric, which might have also contributed and aggravated the signs. The event was casually provided during a communication via. the phone call which was to discuss the expiration of the product and not to report the death of the patient. The level of information is very low. No necropsy was performed. Finally cause for the serious outcome unrelated to the product use and product involvement considered to be unlikely.