Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-6971
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001973
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.
02-SEP-23
5. Location of incident.
Country: CANADA
Prov / State: NEW BRUNSWICK
6. Date incident was first observed.
02-SEP-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. 27581
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Small Dog
- Active Ingredient(s)
- IMIDACLOPRID
- 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 02-Sep-2023, a veterinarian contacted Elanco regarding a possible adverse reaction to Advantage II Small Dog (Imidacloprid, Pyriproxyfen). On 01-Sep-2023 the pet owner applied the product to the cat (misuse incorrect species).
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
7.3
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
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
- Symptom - Ataxia
- Symptom - Muscle tremors
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?
No
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 02-Sep-2023, 12 hours after application, the 5 year old, approximately 7.3kg, neutered, male, Domestic Shorthair cat, developed tremors. On 02-Sep-2023 the cat was seen by an emergency veterinarian and was given Diazepam and Methocarbamol to treat the tremors. The attending veterinarian did not suspect the product was the cause of the tremors. The cat was also wiped with a soapy cloth. On 02-Sep-2023, 4 hours after treatments were administered, the tremors resolved. The cat developed ataxia which, the veterinarian believes, was caused by the treatments for the tremors.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here