Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2871
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_001144
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-APR-24
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
20-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.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: K9 advantix II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- 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 23Apr2024, a veterinary clinic staff member contacted Elanco to report an adverse reaction involving K9 advantix II pipette size unknown (Permethrin, Imidacloprid, Pyriproxyfen). The following was reported: On 20Apr2024, the animal owner applied 1 tube of K9 advantix II pipette size unknown (Permethrin, Imidacloprid, Pyriproxyfen) to a dog. It is unknown if 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?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Shih Tzu
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1.75
7. Weight (provide a range if necessary )
3.6
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Muscle twitching
- Gastrointestinal System
- Symptom - Anorexia
- Symptom - Diarrhea
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
13. Was medical treatment provided? Provide details in question 17.
Yes
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 20Apr2024, 2 hours after the application of K9 advantix II pipette size unknown (Permethrin, Imidacloprid, Pyriproxyfen), the 1.75 year old, 3.6 kg, intact male, Shih Tzu dog, vomited. On 21Apr2024, the dog displayed generalized discomfort and application site pruritus. On 22Apr2024, the dog vomited three times, had diarrhea, and was anorexic. The dog was seen by the veterinarian who found the dog had application site twitching. The dog was given an injection of Maropitant and was dispensed Trimeprazine tartrate and Prednisolone. On 22Apr2024, in the evening, the dog recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here