Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2904
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2024_016436;
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.
18-APR-24
5. Location of incident.
Country: UNITED STATES
Prov / State: TENNESSEE
6. Date incident was first observed.
16-APR-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 Small 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 18-Apr-2024, Elanco was contacted by an animal owner who reported the following adverse event when using a Seresto Small Dog (Flumethrin-Imidacloprid) collar. On approximately 08-Apr-2024, the animal owner placed the Seresto Small Dog (Flumethrin-Imidacloprid) collar around the neck of the dog for flea control. This was the first use of the product and it was used according to the label.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
crossbred chihuahua/ Terrier- unspecified
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
7.250
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Vocalizing
- Symptom - Discomfort
- Symptom - Other
- Specify - Did not want/ was not able to turn his head
12. How long did the symptoms last?
Persisted until death
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
On 16-Apr-2024, the 11 year old, approximately 7.25 kg, intact male, crossbred Chihuahua/ Terrier, in unknown condition, with concomitant medical condition of fleas, began vocalizing and did not want/ was not able to turn his head, which the animal owner attributed to cervical discomfort (discomfort). The dog was not evaluated, and no treatment was performed. The clinical signs continued. On 17-Apr-2024, the dog was found deceased.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here