Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3814

2. Registrant Information.

Registrant Reference Number: 2015KP217

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.

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)

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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 12-Aug-2014, a 13 year old, 8 pound, neutered, female, Shih Tzu canine, in poor condition, with a heart murmur had one 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

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

8

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

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 an unspecified date after application in August 2014 the dog died. No treatments or diagnostics were performed. No necropsy was performed. No more information is expected. Case is closed. Note: The owner initially contacted Bayer to seek advised on how to control an active flea infestation and not to report the death of this pet.

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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. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause death either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Various other causes are more likely in a geriatric dog with poor state of health and history of heart murmur. Moreover, the owner initially contacted Bayer to seek advised on how to control an active flea infestation and not to report the death of this pet and thus was not assuming a relation with the product. No necropsy was performed. Considering the provided data, sufficient information exists to confirm that the product did not cause the event and product involvement remains unlikely.