Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-2115
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_000412
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.
23-MAR-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Extra Large 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 23 Mar 2023 the veterinary technician contacted Elanco regarding a possible adverse effect of K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 100 (Imidacloprid, Moxidectin) in a dog. On unknown dates in 2022 each product was applied separately two weeks apart. On 12 Mar 2023 the pet owner applied 1 tube K9 Advantix II Extra Large Dog.
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
German Shepherd Dog crossbred
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
34.3
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 - Anorexia
- Symptom - Vomiting
- Nervous and Muscular Systems
- Gastrointestinal System
- Symptom - Diarrhea
- Symptom - Abdominal distension
- Specify - Flatulence
- Gastrointestinal System
- Symptom - Other
- Specify - Soft stool
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 an unknown date after each administration of K9 Advantix II and Advantage Multi in 2022, the 5-year-old, 34.3 kg, neutered female, German Shepherd crossbred dog, with no known concomitant medical conditions, exhibited soft stools which would resolve without treatment an unknown time after onset. On 15 Mar 2023, the dog exhibited anorexia, vomiting, diarrhea, eating pine needles (pica), flatulence and restlessness. On 18-Mar-2023 the dog recovered without treatment.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here