Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2899
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2024_013798
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.
04-APR-24
5. Location of incident.
Country: UNITED STATES
Prov / State: TENNESSEE
6. Date incident was first observed.
04-APR-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 04Apr2024, an animal owner contacted Elanco via phone call intending to report an Adverse Event with use of Seresto Cat (Imidacloprid, Flumethrin) in a feline. On 04Apr2024, one Seresto Cat (Imidacloprid, Flumethrin) collar was placed around the neck of a cat by the animal owner for flea and tick prevention. The product was used correctly. The pet owner reported that she had been using Seresto collar for several unspecified years. 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 Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
8.2
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Cardiovascular System
- Symptom - Other
- Specify - Cardiomyopathy
- Gastrointestinal System
- Symptom - Fecal incontinence
- Symptom - Drooling
- Respiratory System
- Symptom - Other
- Specify - Microscopic lesions on lungs
- Cardiovascular System
- Symptom - Other
- Specify - Microscopic lesions on heart
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
One hour post application of the collar applied on 04 Apr 2024, the 7 year old, 8.2 kg, neutered, male, Domestic Shorthair feline, in unknown condition, with no known concurrent medical conditions, exhibited vocalization, drooling and defecation. The cat died. The feline was examined by a veterinarian. On 17Apr2024, a necropsy was performed on the cat and microscopic lesions in the lungs and heart were identified. The cause of death was determined to be feline idiopathic hypertrophic cardiomyopathy.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here