Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1543
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2024_006382
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.
20-FEB-24
5. Location of incident.
Country: UNITED STATES
Prov / State: PENNSYLVANIA
6. Date incident was first observed.
18-FEB-24
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. 11556-191
Product Name: Seresto Cat Collar
- Active Ingredient(s)
- FLUMETHRIN
- Guarantee/concentration 4.5 %
- IMIDACLOPRID
- Guarantee/concentration 10 %
PMRA Registration No.
PMRA Submission No.
EPA Registration No.
Product Name: PERMETHRIN HOME SPRAY (UNSPECIFIED FORMULATION)
PMRA Registration No.
PMRA Submission No.
EPA Registration No.
Product Name: PEPPERMINT (UNSPECIFIED FORMULATION)
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 20Feb2024, an animal owner contacted Elanco regarding a possible adverse event with using Seresto Cat (Imidacloprid, Flumethrin) and reported the following: On 16Feb2024, a feline was shaved and flea bathed by a groomer using dawn dish soap and an unknown de-flea shampoo. The feline then had 1 Seresto Cat (Imidacloprid, Flumethrin) collar placed around his neck by the animal owner. The feline was secondarily exposed to an unknown permethrin home spray and an unknown peppermint spray the animal owner used within the home.
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
Cat / Chat
3. Breed
Himalayan
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
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 18Feb2024, the 10-year-old of unknown weight, neutered, male, Himalayan feline/cat, in unknown condition, with fleas, a history of urinary tract infections with crystals, unspecified gastrointestinal issues, and with mass on his gums that was removed in approximately Aug2023, was found deceased on the couch. A necropsy had not been performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here