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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6954

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0063149 (Report 449352)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-SEP-17

5. Location of incident.

Country: UNITED STATES

Prov / State: ARKANSAS

6. Date incident was first observed.

27-SEP-17

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 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 27-Feb-2017, a unknown old, of unknown weight, male, Unknown cat, 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

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 )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

>6 mos / > 6 mois

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Other
    • Specify - Abnormal test result

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

Within an unspecified amount of time after product application, the cat was evaluated by a veterinarian and diagnosed with cytauzoon. On approximately 27-Sep-2017, the cat died; no necropsy was performed. No further information expected. This case is closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N- Unlikely; In this case, no ticks seen on cat. In case of attachment of ticks these will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. However, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn and simply reflects the labeled claim of efficacy that is not 100% against ticks especially when infestation pressure is high. Thus, infection with tick borne diseases despite wearing a collar can occur exceptionally and is consistent with the products claimed efficacy. This issue is addressed in the product information. No other clinical signs related to the diagnosed tick borne disease were reported. Also unclear when disease was transmitted. Cat may be a mere carrier of the disease. Further the serious outcome like 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Finally, sufficient information exists to rule out product involvement. Overall product relation is unlikely. The feline was examined by a veterinarian and diagnosed with Cytauzoon and passed away. This disease process typically results in death even with intensive medical treatment.