Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-1610
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2022_007124
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.
28-FEB-22
5. Location of incident.
Country: UNITED STATES
Prov / State: FLORIDA
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 Collar Unknown
- 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 28 Feb 2022, the animal owner contacted Elanco regarding a potential adverse event with using Seresto Collar on their cat. On an unknown date, a cat had one Seresto Collar unknown placed around the neck via topical by the animal owner for flea control. It is unknown if this product was used correctly and unknown if any concomitant products were used.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Maine Coon crossbred
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?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Rash
- Symptom - Pruritus
- Symptom - Itchy 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?
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
Approximately 2 weeks later, scratching was noted and the approximately 10-year-old of unknown weight, neutered, male, Maine Coon crossbred cat, in unknown condition, with no known concomitant medical conditions, broke out under his chin. Also experienced hair loss. The animal was given a bath with a gentle shampoo. The cat was deceased on an approximately 1 Feb 2022. Caller threw all collars and packaging away. It was unknown if the cat was seen by a veterinarian and no treatments were performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here