Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4158

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0034497

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.

11-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: WEST VIRGINIA

6. Date incident was first observed.

30-JUN-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 Cat 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).

A 12 year old, male, Domestic Shorthair cat, of unknown weight, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) placed around the neck by the animal 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

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

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

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior of trying to remove the collar
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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 approximately 30-Jun-2016, a 12 year old, male, Domestic Shorthair cat, of unknown weight, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. Approximately 1 hour post application, the cat developed application site pruritus and the behavior of trying to remove the collar. On approximately 14 Jul 2016, the collar was removed and the clinical signs resolved immediately. On an unknown date post removal in 2017, the cat died. No known necropsy was performed and no known medical intervention was sought. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. This 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

O - Unclassifiable/unassessable The reported application site pruritus may occur in sensitive animals after product application. It is usually mild and transient. Sign is consistent. Reported behavioural sign is unspecific and may have numerous other causes. Sign may occur initially after collar administration. Time to onset is short for application site pruritus and behavioural sign. 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 serious signs either. An overdose of 5 collars around the neck was investigated in adult cats for an 8 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. Moreover sign reported long time after collar removal. Owner does not believe in product connection as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Finally, though initial non-serious signs were deemed product related, a relation with death can be clearly ruled out. Hence, the csae was considered as unassessable.