Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-1859
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2022_000414
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.
31-MAR-22
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
30-MAR-22
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 31-Mar-2022 an adverse event was reported to Elanco by a veterinarian regarding K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On 30-Mar-2022, a dog was administered 1 tube of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner in 4 spots 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
Maltese
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.6
7. Weight (provide a range if necessary )
2.6
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
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.
Yes
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 30-Mar-2022 1.5 hours after application of K9 advantix II the 7 month old, 2.6 kg, neutered, female, Maltese dog, in good condition, became lethargic and developed generalized pruritus.
On 31-Mar-2022 the owner contacted the veterinarian and was instructed to apply vitamin E oil to application site. The dog was examined later on in the day as dog was still experiencing symptoms. If the dog has not improved by the end of the day the owner was instructed to give the dog a bath with dish soap and cool water. The owner bathed the dog that night.
On 02-Apr-2022 the dog recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here