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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2771

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0028266 (Report 495025)

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.

08-JUN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

06-JUN-18

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
      • Guarantee/concentration 4.5 %
    • 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 25-May-2018, a 6 year old, 10.3 pound, neutered, female, Domestic Mediumhair feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around her 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

Dog / Chien

3. Breed

Domestic Medium Hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

4.672

kg

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
    • Symptom - Lethargy
    • Symptom - Hiding
    • Symptom - Death
    • Symptom - Other
    • Specify - Abnormal test result
    • Symptom - Parasitism
    • Specify - Cytauxzoonosis

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 06Jun2018, the feline was anorexic, adipsic, lethargic, and hid. On 08Jun2018, the feline was examined by the attending veterinarian. Blood work and a blood smear performed showed that the cat was positive for Cytauxzoonosis. She received an unknown amount of Azithromycin suspension, an unknown amount of fluids by an unknown route, an unknown amount of Atovaquone, and a quarter tablet of aspirin (unspecified). Approximately 4 hours post treatment, the cat died. No necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Reported systemic signs and hiding are unspecific and may have numerous other causes. However in this case, signs may be associated with later diagnosed cytauxzoonosis. In this case, no ticks were 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 product's claimed efficacy. This issue is addressed in the product information. Further reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious sign either. Product has wide margin of safety. Time to onset is long. Although no necropsy was performed, considering safety profile of the product, a product relation is unlikely.