Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6717

2. Registrant Information.

Registrant Reference Number: 2016KP275

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

23-SEP-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

• 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 21-Sep-2016, a 12 year old, 8 pound, neutered, male,Domestic Medium hair feline, in fair condition, with concomitant medical conditions of fleas and pruritus, had 1Seresto 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

Domestic Medium hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

8

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

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

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Hiding
  • Symptom - Lethargy
  • Symptom - Licking
  • Symptom - Abnormal grooming
  • Specify - excessive grooming

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 23Sep2016 the cat exhibited application site dampness as though excessively grooming (application site hair change), hiding, and lethargy, which worsened. The owner removed the collar. On 24 Sep 2016, the owner discovered that the cat had died overnight. No necropsy was performed. Follow up received on 23rd Sep 2016: On 23Sep2016 the cat exhibited application site dampness as though excessively grooming (application site licking), hiding, and lethargy. The owner removed the collar and the lethargy worsened.

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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 described application site dampness is not typically seen with product use. Sign is likely a result of excessive grooming behaviour. Hiding and lethargy are unspecific and may have numerous other causes. Signs may occur initially after collar administration. 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 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. Time to onset is short. Moreover the animal was geriatric and was in fair condition, which may have contributed to the death of the animal. Although no necropsy performed, product involvement is not likely, however due to limited information case is considered unassessable.