Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-3732
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2022_020910
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.
16-MAY-22
5. 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
- 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 16 May 2022 an Animal owner posted on social media regarding an Elanco product with a suspected adverse event using the Seresto collar unknown (Imidacloprid, Flumethrin) on their canine/dog and reported the following: On an unknown date, a dog was applied Seresto collar unknown topically by animal owner for flea control.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Standard Poodle
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Nervous and Muscular Systems
- Gastrointestinal System
- Symptom - Other
- Specify - Dental disease
- Symptom - Weight loss
- General
- Symptom - Neoplasia
- Symptom - Death
- Gastrointestinal System
- Symptom - Other
- Specify - Loosing teeth
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
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, the 5 year old, male, standard poodle dog, in unknown condition and with unknown medical conditions, started having odd seizures and in the summer, he started to loose teeth. The veterinarian cleaned and pulled teeth that were popping out of his mouth and in the winter, the owner removed the collar and the seizures stopped. On an unknown date, the dog, then 7 years old, had fleas and the owner bought the collar again. On an unknown date, the seizures started back up. The owner had done many tests for seizure, weight loss, and teeth falling out. On an unknown date, the owner noticed something in his mouth and had the veterinarian to put him under check his mouth out . The veterinarian pulled more teeth, cleaned and sealed them, and noticed he had a mass half the size of his tongue, which was reported as cancer. On an unknown date, the dog passed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here