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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5429

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0043087 (Report 660111)

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.

21-AUG-20

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

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 large

  • 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 17-Apr-2020, a 4 year old, 59 pound, neutered, female, Retriever - Labrador crossbred dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Retriever - Labrador crossbred dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

26.762

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Stiffness
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Blood
    • Symptom - Other
    • Specify - Elevated Blood Urea Nitrogen
    • Symptom - Other
    • Specify - Elevated creatinine
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Other
    • Specify - Lyme Disease
    • Symptom - Other
    • Specify - Erlichiosis

12. How long did the symptoms last?

Unknown / Inconnu

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?

5

Day(s) / Jour(s)

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 in Jun-2020, the dog developed stiffness. On approximately 10-Aug-2020, the stiffness worsened. On 12-Aug-2020, the dog developed anorexia and adipsia. On 13-Aug-2020, the dog was evaluated by a veterinarian and unspecified bloodwork performed revealed elevated BUN and creatinine, and was positive for Lyme disease and Ehrlichiosis. The dog was hospitalized on intravenous fluids and unspecified intravenous medications. On 17-Aug-2020, the intravenous catheter was removed and oral medications were started. The dog developed emesis. On 18-Aug-2020, the dog 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

O - Unclassifiable/unassessable Reported stiffness is not expected following appropriate topical product application as inconsistent with product真真真s pharmacological profile. Anorexia and adipsia are unspecific signs and may have other causes. Blood parameters such as elevated BUN and creatinine are not expected after product application. In this case signs likely associated with Lyme disease and Ehrlichiosis. Emesis is an unspecific sign and may have other causes. No oral exposure reported. Emesis may be a consequence of elevated renal values. Time to onset is long. Further reported death is not expected 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 period and in 10 week old kittens and 7 week old puppies for a 6 months 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. Ticks 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 (e.g. Lyme disease and Ehrlichiosis) cannot be excluded while the collar is worn and simply reflects the labelled 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真真真s claimed efficacy as addressed in the product information. In this case, no ticks reported. Considering limited information regarding health status and necropsy details, case is considered unassessable.