Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6007

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_031675

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.

Human

4. Date registrant was first informed of the incident.

14-OCT-21

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

01-AUG-21

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 Large 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 14Oct2021, an individual reported several human exposures to the product; this is to report the signs exhibited by the individual's brother in law (as reported by the reporting party). On approximately Aug 2021 (estimated as 1st Aug 2021 for reporting purpose) a 56 year old, of unknown weight, male, human, in unknown condition, with no known concomitant medical conditions, was possibly exposed to an unknown amount of a Seresto Large Dog (Imidacloprid, Flumethrin) collar that had been applied to a canine in another house in Jul2021.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Stomach pain

• Nervous and Muscular Systems
  • Symptom - Difficulty walking

• General
  • Symptom - Pain

• Eye
  • Symptom - Blurred vision

• Gastrointestinal System
  • Symptom - Weight loss

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Caller reports her brother-in-law lost about 30 pounds, had abdominal pain, couldnt walk, neck pain, blurred vision, unexplained body pain.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.