Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4892
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001063
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.
05-JUN-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
04-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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Extra Large 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 05-Jun-2023, an RVT contacted Elanco to report a possible adverse event regarding K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On approximately 01-May-2019, a dog was started on Advantage Multi 100 (Imidacloprid, Moxidectin) topically by the owner, once monthly, seasonally from May to Nov each year. On approximately 03-May-2019 the dog was started on 1 tube of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner once monthly, seasonally, from May to Nov each year. No issues have been reported in previous years with product use. On approximately 03-Jun-2023, 1 tube of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) was applied topically by the owner.
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
St. Bernard/Poodle standard crossbred
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
4.5
7. Weight (provide a range if necessary )
49.5
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
- Nervous and Muscular Systems
- Symptom - Seizure
- Symptom - Disorientation
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
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 04-Jun-2023, the 4.5 year old, of neutered, male, 49.5 kg, St. Bernard/Poodle crossbred dog, in unknown condition, with no known concomitant medical conditions, had one seizure that lasted 20 seconds, and was disorientated. The dog recovered shortly after and has shown no further signs of seizures or disorientation.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here