Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4705
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2023_028748
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.
02-JUN-23
5. Location of incident.
Country: UNITED STATES
Prov / State: CONNECTICUT
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 02 Jun 2023, Elanco was contacted by an animal owner regarding an adverse event with Seresto Large Dog on their dog and reported the following: On an unknown date, the dog was administered Seresto Large Dog via the topical route by the animal owner unknown reason. It is unknown whether the product used correctly or not. No information regarding concomitant products was obtained.
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
Collie
4. Number of animals affected
1
5. Sex
Male
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?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Other
- Specify - Application site lumps
12. How long did the symptoms last?
Unknown / Inconnu
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, 5 days post application, the male, Collie (Unspecified) dog, of an unknown age, weight, and condition, with no known concomitant medical conditions, had application site pruritus and application site skin lumps. On an unknown date, the collar was removed. Approximately 1 day post collar removal, the application site pruritus stopped. Approximately 1 week post collar removal, the application site lumps resolved. It is unknown whether the dog received any treatments. On an unknown date, the dog died.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here