Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1862

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2015-US0026844

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5N 0C9

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

Domestic Animal

4. Date registrant was first informed of the incident.

10-JUN-15

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

04-JUN-15

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)

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

Product Name: Seresto Small Dog Collar

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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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 approximately 13-May-2015, a canine had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Poodle - Toy

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

13

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

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Stiffness

• Gastrointestinal System
  • Symptom - Salivating excessively

• Renal System
  • Symptom - Renal failure
  • Symptom - Urinary incontinence

• Eye
  • Symptom - Blindness (permanent)

• General
  • Symptom - Death

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?

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 approximately 04-Jun-2015, an 11 year old, 13 pound, neutered, female, Poodle (Toy) canine, in good condition, with no known concomitant medical conditions, had a seizure, muscle stiffness and hypersalivated for approximately 4 minutes then resolved. The collar was removed. The dog was examined by a veterinarian. The dog was given an unspecified dose of phenobarbital and intravenous fluids. A blood profile, urinalysis and radiographs were performed and no abnormalities were noted. Update on 23 Mar 2022: Elanco was contacted by an animal owner about the Seresto small dog collar. On an unspecified date in 2019 the dog was diagnosed with kidney failure. On unknown date the dog became incontinent and blind. On an unspecified date in 2019 the dog died. It is unknown if a necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here