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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2217

2. Registrant Information.

Registrant Reference Number: 2017KP161

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.

19-APR-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. 11556-155

Product Name: Seresto Collar - Small Dog

  • Active Ingredient(s)
    • FLUMETHRIN
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 2016, an 11 year old, 14 pound,neutered, male, Yorkshire Terrier canine, in unknown condition, with no known concomitant medical conditions, had1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

14

lbs

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
    • Symptom - Polydipsia
  • Renal System
    • Symptom - Polyuria
  • General
    • Symptom - Other
    • Specify - Diabetes Mellitus

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 unknown date in 2016 post collar application, the canine exhibited lethargy, polydipsia, and polyuria. The canine was examined by a veterinarian, unknown blood work was performed and the canine was diagnosed with diabetic ketoacidosis. It is unknown if any treatments were performed. On an unknown date in Apr2016, the canine died and no necropsy was performed. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected and this case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported lethargy, polydipsia and polyuria are unspecific, however in this cases signs are associated with later diagnosed diabetic ketoacidosis. Diagnosed diabetic ketoacidosis and subsequently reported death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Product has wide margin of safety. Animal involved in this case was geriatic. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Even though some information is not available (e.g. time to onset, health status, medical history and necropsy report), considering known safety profile of the product and the serious outcome of death product relation is deemed to be unlikely.