Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-1260
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2022_001662
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.
14-JAN-22
5. Location of incident.
Country: UNITED STATES
Prov / State: NORTH CAROLINA
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. 11556-152
Product Name: Advantage II Large Cat
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
Units: mL
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 14 Jan 2022, the animal owner contacted Elanco regarding a potential adverse event and a perceived lack of efficacy involving Advantage II for Large Cats. On approximately 11 Dec 2021, the cat was administered 1 tube of Advantage II Large Cat (Over 9 lbs) (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner for flea control.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Longhair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10.5
7. Weight (provide a range if necessary )
3.6
kg
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
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Rash
- Specify - Red bumps
- General
- Symptom - Death
- Symptom - Parasitism
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 an unknown date, the 10.5 year old, 3.6 kg, neutered, female, Domestic longhair cat, in unknown condition, with no known concomitant medical conditions, exhibited red bumps on the skin and live fleas were seen on the cat. On approximately 11 Jan 2022, the cat was not evaluated by a veterinarian, no treatments were performed, and the cat died of an unknown cause. 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