Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-0450
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2021_001438
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
29-NOV-21
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
24-NOV-21
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. 27586
PMRA Submission No.
EPA Registration No. 11556-152
Product Name: Advantage II Large Cat
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
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 29-Nov-2021 an RVT reported on a pet owner's behalf an adverse event regarding Advantage II Large Cat (Imidacloprid, Pyriproxyfen) concerning a cat. On 24-Nov-2021, the cat, in unknown condition, with unknown concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid, Pyriproxyfen) topically by the owner to the base of the neck which would be considered misuse as the dose is too large for the weight of cat.
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
Medical Professional
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 )
1.1
7. Weight (provide a range if necessary )
3.5
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Drooling
- Symptom - Foaming at mouth
- Nervous and Muscular Systems
- General
- Symptom - Abnormal behaviour
12. How long did the symptoms last?
<=30 min / <=30 min
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
Fully Recovered / Complètement rétabli
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 24-Nov-2021 the owner reported the 13 month old, 3.5 kg, intact, female, Domestic Longhair cat, in unknown condition, with unknown concomitant medical conditions, immediately became agitated and was running around the house. The cat then proceeded to drool and foam at the mouth for approximately 5 minutes. After that the cat recovered and returned to normal.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here