Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-0257
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2021_001206
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.
21-OCT-21
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
14-OCT-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. 27584
PMRA Submission No.
EPA Registration No. 11556-130
Product Name: Advantage II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
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 21-Oct-2021 a clinic staff member contacted Elanco regarding an adverse event following the application of Advantage II Extra Large Dog (Imidacloprid, Pyriproxyfen). On 14-Oct-2021 the pet owner applied the product,
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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
American Bulldog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
Unknown
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
<=30 min / <=30 min
11. List all symptoms
System
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
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
5 minutes after application the 2 year old, of unknown weight, female, Bulldog - American canine/dog, in unknown condition, with no known concomitant medical conditions sneezed once, vomited once and recovered without treatment.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here