Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5521
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001314
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.
04-JUL-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
04-JUL-23
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.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: K9 advantix II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 04-Jul-2023, a pet owner contacted Elanco regarding a possible adverse reaction to K9 advantix II pipette size unknown (Permethrin, Imidacloprid, Pyriproxyfen). On approximately 11-Jun-2023 and on 03-Jul-2023, the pet owner applied the product to the dog.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Golden Retriever/Poodle crossbred
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Nervous and Muscular Systems
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 04-Jul-2023, the 11-year-old, approximately 34kg, neutered, male, Golden Retriever/Poodle crossbred dog began limping. At the time of the report the dog had not been seen by a veterinarian. On 07-Jul-2023, the pet owner contacted Elanco with an update to the case. Pet owner feels that the dog is not limping but rather was stopping abruptly to scratch a the application site. On 05-Jul-2023 the pet owner bathed the dog with dish soap. On 06-Jul-2023 the pet owner once again bathed the dog with a dish soap. The dog has improved but has not completely resolved.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here