Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2822
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000972
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.
12-APR-24
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
11-APR-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. 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.
1
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 12 Apr 2024, the attending veterinarian contacted Elanco to report an adverse reaction with K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 10 Apr 2024, the veterinarian applied 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog. The product was used correctly. No concomitant products were administered.
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
Havanese
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
7.5
7. Weight (provide a range if necessary )
6
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
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
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 11 Apr 2024, the 7.5 year old, 6 kilogram, neutered female, Havanese dog began trembling and had application site pruritus. The pet owner bathed the dog with an unspecified shampoo. The veterinarian prescribed Diphenhydramine. The dog was not examined by the veterinarian. On 12 Apr 2024 the signs continued. The veterinarian prescribed Methocarbamol. The dog was not seen by a veterinarian. The dog remains under treatment. The attending veterinarian's suspicion that K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) has a causal association with the clinical signs is medium.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here