Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-3736
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2022_021451
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.
23-MAY-22
5. Location of incident.
Country: UNITED STATES
Prov / State: TENNESSEE
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 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 23 May 2022, Elanco was contacted by an animal owner and incidentally mentioned a potential adverse event with a Seresto Small Dog collar. Starting on an unknown date, the dog had a Seresto Small Dog collar applied every 8 months for an unknown duration.
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
Pomeranian
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
9
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
- General
- Symptom - Other
- Specify - Liver or kidney disease
- Symptom - Death
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
The male, unknown reproductive status, 9 year old, unknown weight, Pomeranian dog, developed seizures on an unknown date and was prescribed phenobarbital for treatment. On an unknown date, the dog developed either liver or kidney disease; the animal owner could not remember which. On an unknown date, the dog died. It is unknown if the dog received other concomitant medications or had other concomitant conditions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here