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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7482

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0067068 (Report 453307)

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.

13-OCT-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. Unknown

Product Name: K9 advantix II pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Other (specify)

spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 unknown date in approximately 2013, a female canine of unknown signalment, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) 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

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Swelling
  • Cardiovascular System
    • Symptom - Other
    • Specify - Cardiac neoplasm
  • 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

Approximately 1 hour post application the canine had applications site swelling. One month post application in 2013, the owner reapplied the K9 Advantix II (unspecified) and the application site swelling worsened. One month post application he owner reapplied the K9 Advantix II Unspecified and the application site swelling worsened. The canine was then examined by a veterinarian and switched to fipronil. On an unknown date in 2013, the application site swelling resolved. On an unknown date in 2013, the canine had a ruptured mass on the heart. The canine was examined by a veterinarian and the chest was tapped. The canine then died. No known 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

N - Unlikely Would not expect swelling development at application site directly related to product, however, dog may have scratched at site and caused sign by self-trauma, though scratching at application site was not reported. Further reported ruptured mass on heart and death are not expected after product application as inconsistent with pharmaco-toxicological product profile. Other causes are more probable. Death in this case, might be associated with ruptured mass on heart. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 4 years). Finally, though time to onset for initial sign is short and even though some minor information missing (age, medical condition, necropsy details are unknown), considering known product safety Profile and fatal outcome, a product connection is deemed to be unlikely.