Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-0717
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2022_002273
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.
02-DEC-22
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
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. 29780
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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 2 Dec 2022, the clinic staff member contacted Elanco regarding an adverse event following K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 55 (Imidacloprid, Moxidectin). From an unknown date in approximately Apr 2022 to Jun 2022, the pet owner topically administered Advantage Multi monthly onto the skin of the patient. From an unknown date in approximately Apr 2022 to Jul 2022, the pet owner topically administered K9 advantix II monthly onto the skin of the patient.
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
Yorkshire Terrier / Maltese Crossbred
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.3
7. Weight (provide a range if necessary )
5.7
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Approximately 2 days after the Jul 2022 K9 Advantix II application, the 16 month old, 5.7 kg, female, neutered, Yorkshire Terrier crossbred, developed facial pruritus and excessive drooling. No treatment or veterinary exam had been done and the patient recovered approximately on the next day.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here