Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2800
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000848
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.
03-APR-24
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
26-MAR-24
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. 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.
2.5
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 03Apr2024, the attending veterinarian contacted Elanco via phone call intending to report an adverse reaction with K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On an unknown date in Mar2023 to Nov2023, the dog was treated with Itraconazole. On an unknown date in Feb2024 the dog was treated with amoxicillin + clavulanic acid for ten days. On an unknown date in Feb2024 the dog was started on phenylpropanolamine. On 25Mar2024 the pet owner applied 1 tube of K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog. The product was used correctly.
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
English Setter
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
20.1
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
- Nervous and Muscular Systems
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 26Mar2024, the 5 year old, 20.1 kilogram, neutered female, English Setter dog, with a history of blastomycosis, a urinary tract infection, and urine incontinence, developed vomiting and diarrhea. On 28Mar2024 the dog had a seizure. On an unknown date, the dog recovered without treatment. The attending veterinarian's suspicion that K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) has a causal association with the clinical signs is low.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here