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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-2796
2. Registrant Information.
Registrant Reference Number: US2023_028020 and US2023_028121 and US2023_28022
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
Domestic Animal
4. Date registrant was first informed of the incident.
05-JUN-235. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
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 Collar unknown
- Active Ingredient(s)
- FLUMETHRIN
- Guarantee/concentration 4.5 %
- IMIDACLOPRID
- Guarantee/concentration 10 %
- FLUMETHRIN
7. b) Type of formulation.
Other (specify)
collarApplication Information
8. Product was applied?
Yes
9. Application Rate.
1Other 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 05 Jun 2023, a pet owner posted on social media regarding a symptomatic human exposure and animal adverse event involving Seresto unknown and reported the following: On unknown dates between 2013 and 2021, a dog and 3 cats were each administered a Seresto collar unknown (Imidacloprid, Flumethrin). The human patient was exposed to the collars in an unknown manner. It is unknown if any concomitant medication was administered.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.
Data Subject
2. Demographic information of data subject
Sex: Male
Age: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
- Nervous and Muscular Systems
- Symptom - Seizure
- General
- Symptom - Lethargy
- Symptom - Subdued
- Specify - Decreased activity
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?
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?
>1 yr / > 1 an
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 male human of unknown age and weight experienced decreased activity (lethargy) after each administration of a new collar to his animals. He also experienced seizures. The seizures were treated with pyridostigmine. On an unknown date one week after stopping use of the Seresto collars in 2021, the seizures resolved.
To be determined by Registrant
14. Severity classification.
Major
15. Provide supplemental information here.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
unknown
4. Number of animals affected
3
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 yr / > 1 an
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Other
- Specify - Organ failure
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On an unknown date after administration, 3 cats of unknown signalment experienced organ failure and died.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
unknown
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 yr / > 1 an
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Other
- Specify - Organ failure
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
An unknown time after administration of the Seresto collar, the dog of unknown signalment experienced organ failure and died.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
