Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-3939

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2022_036189

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.

Human

4. Date registrant was first informed of the incident.

26-JUL-22

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

22-JUL-22

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. 432-1620-11556

Product Name: QuickBayt Spot Spray

• Active Ingredient(s)
  • (Z)-9-TRICOSENE OR MUSCALURE
    • Guarantee/concentration .1 %
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Unknown / Inconnu

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On 26th July 2022 Elanco received human adverse event with unknown of QuickBayt Spot Spray (Imidacloprid, Tricosene). On 21-Jul-2022 a human, was exposed to unknown of QuickBayt Spot Spray (Imidacloprid, Tricosene) via the inhalation route by the patient.

To be determined by Registrant

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

No

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

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Numbness
  • Symptom - Difficulty walking

• General
  • Symptom - Chemical taste in mouth

• Respiratory System
  • Symptom - Nasal congestion

• Cardiovascular System
  • Symptom - Stroke

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

2

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

Drift from the application site

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.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 h

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 22 Jul 2022 the [Age] year old, [Weight], male, human, in unknown condition, with concomitant medical conditions of hypertension, type 2 diabetes, developed numbness on the right side of his face. He also had difficulty walking, a bad taste in his mouth, and his right nostril was stopped up. He went to the emergency room (ER) for an evaluation. On 25 Jul 2022. He was told by the ER staff that he had a stroke. His doctor also thought he may have experienced a stroke due to his symptoms. He went to another ER for a second opinion the same day. That ER also told him he had a stroke. He told the ER staff about using this product and possibly inhaling it through the AC vents. The ER doctor told him his symptoms were not related to this product. He has been admitted in patient to the hospital. A CT scan and MRI were performed as well as some unspecified heart tests which all results came back as being negative. Caller stated that his doctors have not officially said it is related but all signs are pointing back to the product. He stated that when he sprayed, he did not have any ventilation in his home because he did not know he needed it. His symptoms all started the day after he used the product. On 27Jul2022 he was discharged from the hospital and the numbness, bad taste and nasal congestion all resolved while he was in the hospital. He is still having trouble walking, he is using a walker and has a therapist come to the house to work with him on his walking and balance. Caller was able to provide the EPA Reg number for the product and the lot number. He does not currently have any follow ups scheduled with his doctor.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.