Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5734
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2023_037199
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-JUL-23
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 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 18 Jul 2023, an animal owner contacted Elanco regarding a potential lack of efficacy and adverse event after using a Seresto large dog collar (flumethrin/ imidacloprid) on a dog and reported the following: For the last 3 years a dog was administered one Seresto large dog collar (Imidacloprid, Flumethrin) around it's neck every 8 months by the animal owner for flea and tick control. The product was used per label. No concomitant products were administered.
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
Siberian Husky
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 yr / > 1 an
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Parasitism
- Specify - Lyme disease positive
- Renal System
- Symptom - Other
- Specify - Nephritis
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 unknown dates while the 6 year old, male, Siberian Husky, of unknown weight, in unknown condition, with pre-existing ticks was using the Seresto collar, the pet owner found ticks on the dog. On an unknown date the dog tested positive for Lyme disease on an unknown test. The dog was asymptomatic. It is unknown if the dog was examined by a veterinarian or if any treatments were performed. On an unknown date the dog died as a result of Lyme nephritis. It is unknown if a necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here