Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1828
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2024_007837
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.
28-FEB-24
5. Location of incident.
Country: UNITED STATES
Prov / State: OREGON
6. Date incident was first observed.
29-JAN-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. 11556-130
Product Name: Advantage II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Liquid
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 28 Feb 2024, Elanco was contacted by an animal owner regarding an adverse event with use of Advantage II Extra Large Dog on their pet. On approximately 28 Jan 2024, 1 tube of Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) was applied to a dog via the topical route by the animal owner for flea control. It was unknown if the product was used correctly as animal signalment was not provided. No known concomitant products were used.
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
Dog / Chien
3. Breed
Unknown
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Vocalizing
- Symptom - Death
- Symptom - Malaise
- Gastrointestinal System
- Symptom - Loss of appetite
- Symptom - Vomiting
- Nervous and Muscular Systems
12. How long did the symptoms last?
Persisted until death
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
Died
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 approximately 29 Jan 2024, the dog of unknown signalment, in an unknown condition, with no known concomitant medical conditions, became sick (malaise), did not want to eat (loss of appetite), and was sleeping all the time (sleepiness). On approximately 30 Jan 2024, the animal was evaluated by a veterinarian and lab work was performed. No further treatments were reported. On approximately 31 Jan 2024, the animal developed vomiting and crying and then died.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here