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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4222

2. Registrant Information.

Registrant Reference Number: 2016KP126

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-JUL-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar - Cat

  • Active Ingredient(s)
    • Flumethrin
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

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 2015, a 1.5 year old,approximately 14 pound, male, Siamese feline, in good condition with no known concomitant medical conditions, had1 Seresto Cat Collar(Flumethrin-Imidacloprid) 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

Siamese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

14

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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 an unspecified date Nov2015 the cat was hit by a car and died. A necropsy was not performed. No further information is expected. This case is closed. The intent of this call was not to report this death but to inquire on the product.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

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 death either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Further, the owner did not believe in product involvement either as the intent of this call was not to report this death but to inquire on the product. Death was the likely consequence of alternative cause (hitting by car). Time to onset is unknown and even though no necropsy was performed, sufficient information exists to rule out product involvement completely. Overall, a product relation is unlikely.