Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-0254
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2021_001140
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.
19-OCT-21
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
07-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. 27581
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Small 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 19 Oct 2021 Elanco was made aware of an adverse event with Advantage II Small Dog (Imidacloprid, Pyriproxyfen). On an unknown date, the owner applied a tube of Advantage ll Small Dog topically to the dog. Three days later, on an unknown date, the owner accidentally applied a second tube of the product (misuse type: treatment program not expected). Concomitant medications, if any, were not reported.
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
Dog / Chien
3. Breed
Terrier-Yorkshire/ Unknown
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
3.34
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
- Liver
- Symptom - Elevated liver enzymes
- Specify - Elevated ALT
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
Unknown/Inconnu
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 2 year old, 3.34 kg intact male Yorkshire Terrier crossbreed dog underwent routine pre-anesthetic bloodwork prior to being neutered, at which time it was discovered that the dog had an elevated ALT; details were not provided. No other signs had been noted by the owner. No treatment was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here