Health Canada
www.hc-sc.gc.ca
Common menu bar links
Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1304
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000054
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.
15-DEC-235. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
6. Date incident was first observed.
09-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. 27583 PMRA Submission No. EPA Registration No.
Product Name: Advantage II Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 15-Dec-2023, Elanco was made aware of feline that still had fleas after the use of Advantage II (imidacloprid, pyripproxyfen). On 9-Jan-2024, updated information was received and an adverse reaction was reported. On an unknown date in June 2023, Advantage II unknown was applied to the cat. On 8-Jul-2023, 10-Aug-2023, and 01-Sep-2023 the pet owner applied Selamectin for dogs to the cat. On 25-Sep-2023 and 25-Oct-2023, the pet owner applied a partial dose of Advantage II Medium dog to the cat. On 10-Nov-2023, the cat was once again applied Advantage II pipette size unknown by a veterinary staff member.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
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic short hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.7
7. Weight (provide a range if necessary )
Unknown
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 - Other
- Specify - Gastrointestinal foreign body
- General
- Symptom - Parasitism
- Gastrointestinal System
- Symptom - Other
- Specify - Gastric obstruction
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?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
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 09-Nov-2023, the 0.7 year old, male, neutered, Domestic Shorthair cat, of unknown weight, with a history of fleas, underwent emergency surgery to remove a foreign body which was causing a gastric obstruction. The cat was administered an unknown pain medication and an unknown antibiotic. At the time of the surgery the cat still had fleas. The pet owner feels the Advantage II was not as effective as it should have been since she continued seeing fleas all of November 2023. The pet owner reports that she has not seen fleas since early December 2023.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
