Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6006

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_030459

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.

11-OCT-21

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

06-OCT-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 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 04-Oct-2021, a unknown female, human, with concomitant medical conditions of asthma, unspecified allergies and post menopausal was exposed via an unknown manner to Seresto Collar unknown (Flumethrin-Imidacloprid).

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.

Medical Professional

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Headache
  • Symptom - Numbness

• Respiratory System
  • Symptom - Difficulty Breathing

• General
  • Symptom - Pain

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Tingling

• General
  • Symptom - Hemorrhage
  • Specify - Vaginal hemorrhage

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

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?

>24 hrs <=3 days / >24 h <=3 jours

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

On 6 Oct 2021, she had a headache and breathing problems. She went to urgent care twice, where initially a COVID test was done, which came back negative.The second visit was to the ER where they ran tests on her heart, CT scan and checked for blood clots, and all testing came back negative. They though she had mild heart attack, however the tests were negative. She experienced pain in her back, chest, neck, shoulders, numbness and tingling in her hands and arms and reported vaginal bleeding while at the ER. After removing the product from her dog the pain and numbness and tingling started subsiding. Other signs unknown.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.