Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-0427
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2021_001083
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
11-OCT-21
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
11-OCT-21
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 11 Oct 2021, a veterinarian reported an adverse reaction to K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a canine/ dog. On 11 Oct 2021, the dog was administered 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) 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
Schnauzer - Unspecified
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.41
7. Weight (provide a range if necessary )
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 - Difficulty walking
- Symptom - Ataxia
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 11-Oct-2021, at an unknown time after application but on the same day the 5 month old, 5 kilogram, intact, female, Schnauzer - Unspecified canine/dog, in unknown condition, with concomitant medical conditions of ticks, became ataxic and had difficulty walking. The dog was washed with water. On 12 Oct 2021 the dog was seen by a veterinarian who indicated the initial symptoms had improved but the dog had back pain.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here