Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3875

2. Registrant Information.

Registrant Reference Number: 2015TH287

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.

22-OCT-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).

owner applied collar Oct 19 2013

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

miniature daschund

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.5

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Swelling
  • Symptom - Abnormal behaviour

• Nervous and Muscular Systems
  • Symptom - Shaking

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 19Oct2013, a 12.5 year old, 8 pound, spayed, female, Dachshund (Miniature) canine, in good condition, with periodontal disease, had the Seresto Small Dog (Flumethrin- Imidacloprid) collar placed around her neck by the owner.Approximately 1 hour post administration the dog had facial and application site swelling and was shaking (behavioral). The dog was not examined by a veterinarian. The owner immediately removed the collar.Approximately 10 minutes following removal the dog's clinical signs resolved. On approximately 21Oct2013 the dog was not acting like herself (behavioral) and was not examined by a veterinarian. On 22Oct2013 the dog passed away at home. A necropsy was not performed.

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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 First described symptom is in line with a hypersensitivity reaction and time to onset consistent. However, product has very low allergic potential. Though allergic reactions are possible to any product, various other causes (e.g. bee sting) must be considered as well. Behavioural reaction and subsequent death occurred long time after removal of collar. It is not unusual for a dog of 12.5 years of age to finally pass away, particularly in miniature breeds health defects are known. The dog was not examined by a veterinarian and a necropsy was not performed. However, overall, a product relation is deemed to be unlikely.