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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1306
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000137
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.
17-JAN-245. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
15-NOV-23Product 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. 29780 PMRA Submission No. EPA Registration No.
Product Name: K9 Advantix II Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5Units: 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 17 Jan 2024, a veterinary technician contacted Elanco to report an adverse event involving K9 Advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 55 (Imidacloprid, Moxidectin) and a dog. Between 14 Apr 2023 and 27 Oct 2023, the dog was treated monthly and topically with K9 Advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). Between 28 Apr 2023 and 10 Nov 2023, the patient was also treated monthly and topically with Advantage Multi 55 (Imidacloprid, Moxidectin).To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Siberian Husky
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
20.5
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>6 mos <=1 yr / > 6 mois < = 1 an
10. Time between exposure and onset of symptoms
>6 mos / > 6 mois
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Erythema
- Symptom - Lesion
- Symptom - Dermatitis
- Specify - Application site crust
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 15 Nov 2023, the 8-year-old, 20.5 kg, neutered female, Siberian Husky dog, in good condition, with a history of malignant cancerous mass removal on a hind limb, experienced hair loss at the application sites. On 25 Nov 2023, the dog was seen by a veterinarian who reported the dog had multiple lesions with hair loss, erythema, and application site crusts measuring between 4-8 cm in diameter. There were four lesions in total: one caudal to the right shoulder, on the dorsal aspect of the neck, lumbar area, and base of the tail. The cytology of the lesions, Wood's lamp exam and dermatophytosis polymerase chain reaction test were all negative. Treatment consisted of a chlorhexidine topical solution and cephalexin. On 28 Dec 2023, a re-evaluation showed ongoing crusts with improved erythema. All signs were ongoing.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
