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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5437

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0045215 (Report 662725)

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

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

Domestic Animal

4. Date registrant was first informed of the incident.

01-SEP-20

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 unknown

  • 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 an unknown date in approximately Jan 2020, a female, canine, of unknown breed, reproductive status, age, weight and condition, with no known concomitant medical conditions, had one Seresto Dog (Unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. This collar was stiffer and a darker color than previous collars applied.

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

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Blood
    • Symptom - Other
    • Specify - Immune mediated haemolytic anaemia
  • Skin
    • Symptom - Rash

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 unknown date in Feb2020, the dog was examined by a veterinarian and diagnosed with immune mediated hemalytic anemia. On an unknown date in Feb2020, the dog had an application site rash. On an unknown date in Feb 2020, the dog died. It is unknown if a 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

O - Unclassifiable/unassessable Diagnosed immune mediated haemolytic anaemia is not expected following appropriate topical product application as inconsistent with product真真真s pharmacological profile. Time to onset is unknown. Other unrelated causes are more probable. The reported application site rash may occur in sensitive animals after product application. It is usually mild and transient. Onset time is unknown. Later reported, serious outcome of death is not expected following appropriate topical product application as inconsistent with product真真真s 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真真真 period and in 10 week old kittens and 7 week old puppies for a 6 months真真真 period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Death in the dog is most likely the consequence of immune mediated haemolytic anaemia. Overall, considering unknown time to onset and limited information about medical history, health status, animal details and necropsy report of animal, a product involvement is unassessable.