Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0568

2. Registrant Information.

Registrant Reference Number: 2017KP071

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.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

06-OCT-16

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 - Cat

• 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 14-Sep-2016, a 12 year old, 7 pound, neutered, male,Maine Coon Cat feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Catcollar(Flumethrin-Imidacloprid) applied 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

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

7

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Convulsions
  • Symptom - Seizure

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 06-Oct-2016, the feline devloped seizures. The feline was taken into a veterinary clinic for evaluation. The feline had a complete blood count, chemistry, Vetscan, FIV test, and blood pressure taken but the results were not provided. The feline was given Prednisone. On approximately 09-Oct-2016, the feline was doing better. On 10-Oct-2016, the feline died. It is not known if a necropsy was conducted. No additional information expected. Case closed. Follow-up received on 14th Oct 2016: On 14-Sep-2016, a 12 year old, 7 pound, neutered, male, Maine Coon Cat feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat collar(Flumethrin-Imidacloprid) applied by the owner. On 07-Oct-2016, the feline developed seizures. The feline was examined by the veterinarian. A complete blood count, blood chemistry, unspecified blood gas, a feline immunodeficiency virus test, and blood pressure were performed; the results are unknown. The feline was administered an unspecified dose of prednisone. On approximately 09-Oct-2016, the clinical signs continued but improved. On 10-Oct-2016, the feline died. No necropsy was performed. No additional 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

The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Death is not expected either as inconsistent with pharmacotoxicological product profile. Overdose of 5 collars around the neck of 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 did not cause serious signs either. Even with oral product exposure, serious signs are not expected. Merely gastrointestinal signs would be possible. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Time to onset is not suggestive of product involvement. Other causes are more probable in this advanced aged cat. Although unknown if necropsy was performed, considering the known product profile sufficient information exists to conclude that the product did not cause the serious event and hence product involvement is unlikely.