Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0578

2. Registrant Information.

Registrant Reference Number: 2017KP081

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.

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 - 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 an unspecified date in 2016, a 12 year old, neutered,male, Unknown Breed feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat(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

Cat / Chat

3. Breed

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Constipation

• Cardiovascular System
  • Symptom - Cardiac arrest

• General
  • Symptom - Other
  • Specify - Multi organ failure

• Gastrointestinal System
  • Symptom - Other
  • Specify - Digestive tract stenosis and obstruction

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 unspecified date in May-2016, the cat exhibited intermittent vomiting. On an unspecified date in Jun-2016, the cat exhibited a constipation and was examined by a veterinarian. Radiographs were performed and the cat was diagnosed with a partial intestinal obstruction. On an unspecified date in Aug-2016, the cat was diagnosed with multiple organ failure. On 27-Aug-2016, the cat was examined by an emergency veterinarian, went into cardiac arrest, and died. No necropsy was performed. 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 expiration date not to report the death of the patient. No further information is expected. 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

Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Mild gastrointestinal signs may occur shortly after product application, however, time to onset of sign is unknown. No oral product exposure reported. Constipation is not anticipated with appropriate topical product administration. In this case it is likely associated with the later diagnosed partial intestinal obstruction. The reported serious signs like multiple organ failure, cardiac arrest and death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Time to onset is unknown, however, seems long. Oral exposure to the collar is not expected to cause such signs either. An overdose of 5 collars around the neck was investigated in 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 without causing serious signs. Moreover, the reason for the initial phone call was to ask for expiration date and not to report the death of the patient. Animal involved in this case was geriatric which may have further contributed the signs. Even though some information is not available (health status, medical history, time to onset and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product relation is considered as unlikely.