Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-6177
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2022_050439
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.
28-SEP-22
5. Location of incident.
Country: UNITED STATES
Prov / State: MISSOURI
6. Date incident was first observed.
15-JUL-22
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 28-Sep-2022, Elanco was contacted by an animal owner regarding a perceived lack of efficacy with use of Seresto Small dog collar on their pet. On approximately 15-Oct-2021, a dog had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. The animal was bathed once every 2 weeks with an oatmeal and aloe shampoo. On approximately 15-Jun-2022, the animal owner removed the collar and placed one new Seresto Small Dog (Flumethrin-Imidacloprid) collar around the animal's neck. The animal was bathed once every 2 weeks with an oatmeal and aloe shampoo.
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
Shih Tzu
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
14
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>6 mos <=1 yr / > 6 mois < = 1 an
10. Time between exposure and onset of symptoms
>6 mos / > 6 mois
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Parasitism
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
On approximately 15-Jul-2022, the animal owner visualized fleas on the 14-year-old, of unknown weight, neutered, female, Shih Tzu dog, in unknown condition, with no known concomitant medical conditions. On 28-Sep-2022, the animal passed away this morning due to a stroke.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here