Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-4891
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2022_001309
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.
19-JUL-22
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
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. 29777
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Small 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 19 Jul 2022 a pet owner contacted Elanco and reported an adverse event involving K9 Advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen). On an unknown date in approximately Jun2022, the dog was administered 1 tube of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner (misuse: underdose). This was the first use of the product.
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
Shih Tzu / Pekingese
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
13
7. Weight (provide a range if necessary )
7.3
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Specify - Rolling
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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 application, the 13 year old, approximately 7.3 kilogram, crossbred Shih Tzu/ Pekingese canine/dog, in unknown condition, with no known concomitant medical conditions, experienced itchiness, was scratching (itchy skin), and rolling. On an unknown date in Jun2022, 3 days post onset of the symptoms, the dog was bathed and recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here