Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-3996
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_000986
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-MAY-23
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
30-MAY-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. 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.
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 30 May 2023, a pet owner contacted Elanco regarding a possible adverse reaction to K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) with their dog. On 30 May 2023, the dog chewed on the product package and pierced at least one tube. None of the tubes were ingested. It was unknown if some of the product was ingested (misuse route).
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
Labrador Retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
Unknown
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 / <=30 min
11. List all symptoms
System
- Respiratory System
- Symptom - Heavy breathing
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
Unknown/Inconnu
16. How was the animal exposed?
Other / Autre
specify UNKNOWN
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On 30 May 2023, approximately 30 minutes after chewing the product, the 1-year-old, unknown weight, neutered, female, Labrador Retriever dog, in unknown condition, with no concomitant medical conditions, was breathing more heavily than usual. The pet owner and dog were in a vehicle and the pet owner commented he did not know if the sign was due to the heat or the product.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here