Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2299
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2024_012128
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.
26-MAR-24
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
26-MAR-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 %
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 26 Mar 2024, an animal owner contacted Elanco for a potential adverse event involving a Seresto Cat collar on a feline and reported the following: On 26 Feb 2024, a feline had a Seresto Cat (Imidacloprid, Flumethrin) collar placed around the neck by the animal owner. 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
Cat / Chat
3. Breed
Domestic mediumhair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
13
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Nervous and Muscular Systems
- Skin
- Symptom - Other
- Specify - Low skin temperature
- General
- Symptom - Hesitancy to move
- Specify - Unable to move
- Respiratory System
- Symptom - Shortness of breath
12. How long did the symptoms last?
Persisted until death
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 25 Mar 2024, the 13-year-old, unknown weight, female/neutered, Domestic Medium hair feline in unknown condition, with no known concomitant medical conditions, was bathed in an unknown shampoo. On 26 Mar 2024, the cat was not moving, cold to the touch, had stiff muscles, a faint heart rate and shallow breathing. The cat has not been examined at the time of the call. The cat died at home of unknown causes at home before getting her to the vet. The cat was not examined, owner did not take her at all and no 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