Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-1615
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2023_006204
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.
15-FEB-23
5. Location of incident.
Country: UNITED STATES
Prov / State: NORTH CAROLINA
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 15 Feb 2023, an animal owner contacted Elanco regarding a lack of efficacy after using Seresto small dog (Flumethrin-Imidacloprid) on a dog and reported following: On an unknown date, a dog was administered 1 collar of Seresto Small Dog via the topical route by the animal owner for the flea control. The product was used correctly. It was unknown whether concomitant products were administered. The dog has been using a Seresto collar since the dog was a puppy and would get new collar every 7-7.5 months, occasionally sooner if the dog was going into water frequently. The collar would be removed during grooming sessions and then put back on after. The most recent collar was placed on dog approximately 1 month ago.
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
Terrier - Yorkshire
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
7.3
kg
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
>6 mos / > 6 mois
11. List all symptoms
System
- Renal System
- Symptom - Other
- Specify - Nephritis
- General
- Symptom - Parasitism
- Specify - Lyme Disease
12. How long did the symptoms last?
Persisted until death
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 in Jan 2023, the 8-year-old, 7.3 kg, neutered, male, Yorkshire Terrier dog, in unknown condition, with no known concomitant medical conditions, tested positive for Lyme disease and was placed on a 30-day course of an unspecified antibiotic. There were no symptoms before diagnosis. On 03 Feb 2023 the dog developed Lyme nephritis and was brought to an emergency veterinarian. On 06 Feb 2023 the dog was taken to an internal medicine veterinarian where ultrasounds were performed. On 08 Feb 2023 the dog died. It is unknown what other treatments or diagnostics may have been performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here