Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2898
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_001234
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.
30-APR-24
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
23-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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- 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 30 Apr 2024 a veterinary technician contacted Elanco to report a possible adverse event involving K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 23 Apr 2024, the dog was administered 1 tube of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) once, correctly applied via the topical route by the owner. The dog had received previous doses of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) without incident. There were no reported concomitant medications.
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
Retriever - Golden
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
42.41
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Paresthesia
- Symptom - Skin sensitivity
- Symptom - Other
- Specify - Jumpy when application site was touched
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
Not recovered / Non 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 23 Apr 2024, an unknown time after product application, the 5 year old, 42.41 kilogram, male neutered, Golden Retriever dog, in good condition and no reported concurrent illnesses, developed crawling skin (paraesthesia), sensitivity to touch at site of application (paraesthesia), and was jumpy when application site was touched (paresthesia). On 24 Apr 2024, the animal owner informed veterinary clinic staff that the symptoms were ongoing but improving. The owner started oral diphenhydramine tablets as treatment for the symptoms.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here