Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0730

2. Registrant Information.

Registrant Reference Number: 2015KP357

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.

15-JAN-16

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

• 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 an unknown date in approximately Apr2015, a 8 year old,male, Retriever (Golden) canine, with an unknown weight, in fair condition, who is overweight, had 1 Seresto Dog(unspecified) (Flumethrin-Imidacloprid) collar placed aroundhis neck by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

Unknown

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 - Other
  • Specify - Skeletal Disorders

• Nervous and Muscular Systems
  • Symptom - Difficulty walking
  • Specify - Limping
  • Symptom - Lameness
  • Symptom - Paralysis

• General
  • Symptom - Adipsia

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 approximately Jun2015, the dog developed an unknown musculoskeletal disorder. On an unknown date in approximately Jun2015, the dog developed a limp on his right leg which progressed to lameness. Approximately 1 week following right leg limp, the dog developed lameness in his left leg, which progressed to complete paralysis. On an unknown date, the dog was examined by a veterinarian where radiographs showed no significant findings. It is unknown if treatments were performed. Approximately 3 days post veterinary visit, the dog was adipsic. On approximately 01Oct2015, the dog passed away. It is unknown if a necropsy was performed. No further information expected. Case 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

Reported musculoskeletal disorders are not expected as not in line with the pharmaco-toxicological product profile. Paralysis too is not anticipated with product use and may rather have occured due to progression of the initial musculoskeletal disorder. Adipsia is an unspecific sign with multiple other possible causes. Finally, death is not expected following appropriate topical product application or even oral exposure as inconsistent with products pharmacological profile. The exceptionally long time to onset, prolonged clinical course and the ultimate fatal outcome in this dog in a fair state of health is suggestive of other severe underlying conditions. Although it is unknown if necropsy was performed, considering all aspects, product relation was deemed to be unlikely.