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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5725
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2023_034372
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.
05-JUL-235. 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. 11556-191
Product Name: Seresto Cat Collar
- Active Ingredient(s)
- FLUMETHRIN
- Guarantee/concentration 4.5 %
- IMIDACLOPRID
- Guarantee/concentration 10 %
- FLUMETHRIN
7. b) Type of formulation.
Other (specify)
collarApplication Information
8. Product was applied?
Yes
9. Application Rate.
1Other 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 05 Jul 2023, an animal owner contacted Elanco regarding an inquiry and mentioned an adverse event involving a Seresto Cat Collar (flumethrin/ imidacloprid) in a cat and reported the following: On an unknown date, a cat was administered a Seresto Cat Collar by the animal owner. The product was used correctly. No concomitant medications were reported.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Unknown
4. Number of animals affected
1
5. Sex
Male
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?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Gastrointestinal System
- Symptom - Vomiting
- Renal System
- Symptom - Renal failure
- General
- Symptom - Abnormal behaviour
- Skin
- Symptom - Red skin
- Symptom - Dermatitis
- Specify - Raw skin
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?
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 after administration of the collar, the 13 year old, male, unknown weight, breed, and reproductive status, cat, in unknown health, with a pre-existing history of having topical adverse reactions to topical flea medications, experienced redness and rawness around the neck under the Seresto Collar. The owner removed the collar. No treatment was performed and the area healed on an unknown date. On an unknown date, the cat began vomiting his food. The cat was examined by a veterinarian and bloodwork and a urinalysis were performed and were within normal limits. The owner indicated that the cat was eating too fast (abnormal behavior) competing for food with other cats in the home, resulting in the vomiting. The owner changed the cats food to a sensitive skin and stomach food and the vomiting resolved. On an unknown date, the cat passed away from kidney failure.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
