Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2288
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000739
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.
21-MAR-24
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
19-MAR-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 21Mar2024, a pet owner contacted Elanco via phone call to report an adverse reaction with K9 advantix II Medium Dog. On 18Mar2024, the pet owner applied 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) to a dog. This was a first time use of the product and was applied correctly.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Crossbred unspecified Poodle/ Shih Tzu
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.9
7. Weight (provide a range if necessary )
5.9
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Insomnia
- Specify - Disturbed sleep
- 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
Unknown/Inconnu
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 19Mar2024, the 0.9 year old, 5.9 kilogram, neutered female, crossbred unspecified poodle/ shih tzu, dog, began to bite (biting) at the base of her tail (this was not an application site). On 20Mar2024 the dog began to rub and scratch (pruritus) at the application site, had disturbed sleep, and was anxious. The pet owner washed the application site with a dog shampoo. The dog was not examined by a veterinarian. At the time of the report the symptoms were ongoing. The outcome of this case is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here