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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-6552
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001681
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.
09-AUG-235. Location of incident.
Country: CANADA
Prov / State: QUEBEC
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
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.
.4Units: 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 9 Aug 2023, the veterinary clinic's staff contacted the Elanco after hours service regarding an adverse event in a dog following application of K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) and K9 Advantix II small dog (Permethrin, Imidacloprid, Pyriproxyfen). On an unknown date in April 2021, K9 Advantix II small dog was applied to the dog. On 06 Aug 2023, K9 Advantix II medium dog was applied to the dog (misuse: overdose).To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Poodle - Toy
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
3.2
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
- Gastrointestinal System
- Symptom - Vomiting
- Skin
- Symptom - Pruritus
12. How long did the symptoms last?
Unknown / Inconnu
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
Not recovered / Non 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 an unknown date in April 2021, the day after application of K9 Advantix II small dog, the 3 year old, 3.2 kg, spayed female, Toy Poodle dog, with no reported concomitant medical conditions, experienced vomiting which resolved without treatment the same day. On 06 Aug 2023, an unknown time after administration of K9 Advantix II medium dog, the dog experienced generalized pruritus. On 9 Aug 2023, the pet owner contacted the veterinary clinic and was instructed to apply Vitamin E at the application site. No improvement was noted. The clinic recommended to bathe the dog with a dish soap which the owner did three times, followed by a fourth bath with a dog oatmeal base shampoo. On 10 Aug 2023, the clinic contacted the owner and was informed that the pruritus was mostly resolved except for the facial region.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
