Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1545
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2024_007387
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.
Domestic Animal
4. Date registrant was first informed of the incident.
26-FEB-24
5. Location of incident.
Country: UNITED STATES
Prov / State: MAINE
6. Date incident was first observed.
05-FEB-24
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 26Feb2024, a clinic staff member contacted Elanco for a potential product defect and adverse event involving a Seresto Large Dog collar. On approximately 01-Feb-2023, a dog had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner for flea control. The product was used correctly and no concomitant products were used.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Golden - Retriever crossbred
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
27
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Nausea
- Symptom - Anorexia
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
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
The ink printed on the side of the canister was lighter than expected. The owner alleges this must be counterfeit. On approximately 05Feb2023, the 9 year old, 27 kg, female, Retriever - Golden crossbred dog, of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, developed anorexia and nausea. The Seresto Large Dog (Flumethrin-Imidacloprid) collar was removed. On approximately 07Feb2023, the clinical signs stopped without any treatment. On approximately 01Dec2023, the dog died. No necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here