Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-1019
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2022_006342
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.
22-FEB-22
5. Location of incident.
Country: UNITED STATES
Prov / State: ILLINOIS
6. Date incident was first observed.
Unknown
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)
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 %
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 22 Feb 2022, Elanco was contacted by animal owner regarding a potential Human Exposure involving Seresto Large Dog collar. On an unknown date, one Seresto Large Dog collar was applied to the 1 year old, approximately 8.6kg, neutered, female, French Bulldog. The boy, in unknown condition, with no known concomitant medical conditions, had been around the dog during the same time frame.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
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: >1 <=6 yrs / > 1 < = 6 ans
3. List all symptoms, using the selections below.
System
- Nervous and Muscular Systems
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
Non-occupational
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.)
On an unknown date, the 6-year-old boy had seizures.
To be determined by Registrant
14. Severity classification.
Major
15. Provide supplemental information here.