Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4378

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001560 and CA2022_001559

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.

17-AUG-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-AUG-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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Medium Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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-Aug-2022, a pet owner contacted Elanco regarding adverse events following a secondary exposure to K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 17-Aug-2022 the pet owner applied the product to her dog.

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: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Hives

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

Non-occupational

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

Contact with treated area

Amount of time between application and contact .01

Hour(s) / Heure(s)

What was the activity? Touching the dog and then touching his nose

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.

Skin

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.)

On 17-Aug-2022 Immediately after application the pet owner's 6 year old, 24.5kg son touched the dog and then touched his own nose. The 6 year old boy washed his hands and face after the exposure. On 17-Aug-2022, an unknown time after exposure, the boy had a hive on his face. On 17-Aug-2022, 3 hours after exposure, the hive had improved but not resolved.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

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: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Dry skin

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

Non-occupational

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

Application

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.

Skin

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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 17-Aug-2022 a female human of unknown weight and age touched the product with her hands while applying the product to her dog. She immediately washed her hands with soap and water. After washing her hands she reported her hands were somewhat dry.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.