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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4951

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0046888

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.

26-JUL-17

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. 11556-117

Product Name: Advantage 10 Topical Solution

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

7. b) Type of formulation.

Other (specify)

Spot-on

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).

1 Tube/Pipette 1 Days 1 Dose

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

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

2.268

kg

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

  • Gastrointestinal System
    • Symptom - Bad breath
    • Specify - Halitosis
  • General
    • Symptom - Death

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?

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

Approximately 6 hours post administration, the canine developed halitosis that smelled like product. The canine recovered the next day with no medical treatment. On an unknown date in 2003 post application the canine died. 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

The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. This case is closed. N-Unlikely:The product is not expected to cause halitosis in the treated dog. As oral ingestion of product was not reported, other causes (e.g. diet, tartar) have to be considered in this case. Apart from that, the smell of any agent is subjective to the individual concerned. Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. No signs of allergy/anaphylactic reaction reported. Further, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Finally, even though some information is missing (medical history, time to onset for serious sign and necropsy result) considering known product profile and unexpected fatal outcome, a product involvement is deemed to be unlikely.