Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5549
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001422
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.
14-JUL-23
5. Location of incident.
Country: CANADA
Prov / State: ALBERTA
6. Date incident was first observed.
12-JUN-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.
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 14-Jul-2023 an RVT contacted Elanco to report a possible adverse event regarding K9 advantix II Medium Dog on their pet and reported the following: On approximately 11-Jun-2023 and on approximately 09-Jul-2023, the dog was administered K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner along the dorsal midline.
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
Shih Tzu/Miniature Poodle crossbred
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
4
7. Weight (provide a range if necessary )
7
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Muscle twitching
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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
On approximately 12-Jun-2023, 24 hours post application, the 4-year-old, 7 kg, neutered, male, Shih Tzu/Miniature Poodle crossbred dog, in good condition, with unknown concomitant medical conditions, became lethargic and developed muscle twitching. On approximately 18-Jun-2023 the dog recovered. On approximately 10-Jul-2023 following the application the dog became lethargic and developed muscle twitching. On approximately 16-Jul-2023 the dog recovered. The animal was not evaluated by a veterinarian.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here