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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3864

2. Registrant Information.

Registrant Reference Number: 2015TH276

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Blvd

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L9W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

05-AUG-15

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

  • 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).

owner applied collar

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

unknown

4. Number of animals affected

1

5. Sex

Male

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 mo <= 6 mos / > 1 mois < = 6 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

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, a male, canine, of unknown signalment, in unknown condition, with no known concomitant medical conditions, had 1 Seresto (unspecified) (Flumethrin- Imidacloprid) collar placed around the neck by the owner. Approximately 2 months later, on an unknown date, the dog died. It is unknown whether or not a 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. Death would not be expected following use of the product; even not following oral ingestion or overdose. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. Onset time not suggestive of product involvement as obviously the collar was tolerated well for 2 months. No signs of anaphylaxis reported which would have been expected to occur in close proximity to the collar application. Signs are not consistent with pharm-tox product profile. Limited information about treated animal. Unknown, why death occured. Unknown, if a necropsy was performed. But considering the provided chronology and the product's pharmacological profile, sufficient information exists to confirm that the product did not cause the event and product involvement was ruled out.