Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4910
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001097
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.
11-JUN-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
11-JUN-23
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. 27582
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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 11-Jun-2023, a pet owner contacted Elanco regarding a possible adverse reaction to Advantage II Large Dog (Imidacloprid, Pyriproxyfen) in a dog. On 10-Jun-2023, right before midnight, the pet owner applied the product to the dog (misuse overdose). The dog had this product applied several times in the past without issue.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
crossbred Jack Russell Terrier/ Pomeranian
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
9.5
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 / <=30 min
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Nervous and Muscular Systems
- Nervous and Muscular Systems
- Symptom - Other
- Specify - Paranoid
12. How long did the symptoms last?
Unknown / Inconnu
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
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 11-Jun-2023, approximately 30 minutes after application, the 11 year old, approximately 9.5kg, neutered, male, Jack Russell Terrier/Pomeranian crossbred dog, was paranoid then playful (abnormal behavior), panting, and irritable. On 11-Jun-2023, approximately 2 hours after application, the dog vomited. The dog continued to vomit several times throughout the day. On 11-jun-2023, approximately 12 hours after onset, the vomiting resolved without treatment. On 14-Jun-2023 the dog had improved but not fully recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here