Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3820

2. Registrant Information.

Registrant Reference Number: 2015KP174

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

Address: 2920 Matheson Boulevard

City: Missisaugua

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.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

01-DEC-13

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)

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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 %

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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 07-May-2013, a 3 year old, 13.6 pound, neutered, male, Rat Terrier canine, in good condition, with no known concomitant medical conditions, had one Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the attending vet.

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

Rat terrier

4. Number of animals affected

1

5. Sex

Male

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

13.6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

>6 mos / > 6 mois

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Other
  • Specify - Trauma

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?

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 01Dec2013, six months following the placement of the collar, the dog was hit by a car and died. No necropsy was performed. Updated information 08.05.2014: No more information is expected and the case is closed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely. Signs reported clearly related to fatal car accident. No relation in time. There is no plausible connection at all to the product. Case is assessed unlikely.