Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2268
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000537
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.
06-MAR-24
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
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 6 Mar 2024, a veterinary technician contacted Elanco to report an adverse event in a canine that had been treated with K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 55 (Imidacloprid, Moxidectin). On 15 Apr 2023, the pet owner treated the dog with 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically, as per label. On 15 May 2023, the pet owner treated the dog again with 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically, as per label, along with vitamin E at the application site prior to treatment. On 1 Jun 2023, the pet owner treated with dog with 1 tube of Advantage Multi 55 (Imidacloprid, Moxidectin) topically, as per label.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Shepherd Dog - Australian
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3.5
7. Weight (provide a range if necessary )
11.8
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
Unknown / Inconnu
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
An unknown time after the first application of K9 Advantix II, the 3.5 year old, 11.8kg, intact male, Australian Shephard dog, in good condition, with no concomitant conditions, experienced application site discomfort and scratching (pruritus). An unknown time after the second application of K9 Advantix II, the dog again experienced application site discomfort and scratching. An unknown time after application of Advantage Multi 55, the dog experienced application site discomfort and scratching. No veterinary exam or treatment was done. On an unknown date the dog recovered from all signs.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here