Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2869
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_001138
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.
23-APR-24
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
17-APR-24
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. 29778
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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 23 Apr 2024, a veterinary technician contacted Elanco via phone call to report an adverse reaction in a canine involving an extra label use with K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 17 Apr 2024, a dog was administered 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) once, via the oral route, by the animal owner for parasite control. The product was not used correctly (route). No concomitant products were administered.
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
pug
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
12
kg
8. Route(s) of exposure
Oral
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
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
On 17 Apr 2024, one hour following administration, the 6 year old, 12 kilograms, neutered male, pug canine, in good condition, with no medical history, exhibited vomiting. The dog was not examined by a veterinarian and was not treated. On 18 Apr 2024, the dog recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here