Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2291
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000758
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.
20-MAR-24
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 20 Mar 2024, a veterinarian contacted Elanco via email to report an adverse reaction with K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). Further information was received by phone call from the veterinary technician on 22 Mar 2024. The following was reported: On 04Mar2024, the pet owner applied 1 tube of K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog, The product was used correctly. The dog was also receiving anti-epileptic medication.
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
Crossbred Golden Retriever/ unspecified Poodle
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
9.25
7. Weight (provide a range if necessary )
29.7
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
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Red skin
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
No
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 an unknown date after application, the 9.25-year-old, 29.7 kg, neutered male crossbred Golden Retriever/ unspecified Poodle dog, with concomitant medical conditions of being treated for tremors, developed application site pruritus and application site redness. It was unknown whether the dog recovered. The dog was not examined by a veterinarian. The veterinarian did recommend applying Vitamin E to the application site. It is unknown if the vitamin E was applied.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here