Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1621
2. Registrant Information.
Registrant Reference Number: 2023-CA-000054
Registrant Name (Full Legal Name no abbreviations): Ceva Animal Health Inc.
Address: 150 Research Lane, Suite 225
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
13-JUN-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
13-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. 33420
PMRA Submission No.
EPA Registration No.
Product Name: VECTRA 3D DOGS & PUPPIES OVER 7 WEEKS WEIGHING 9.1 KG TO 25 KG
- Active Ingredient(s)
- DINOTEFURAN
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
3.6
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 June 13th, the pet-owner applied on the whole body, and right away, the dog became depressed/rubbing his back and unsettled. After about 6 hours the pet-owner washed the dog and removed all product.
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
Mixed breed
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
9.540
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>2 hrs <=8 hrs / >2 h <=8 h
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Specify - Rubbing the skin
- Nervous and Muscular Systems
- Symptom - Depression
- Symptom - Other
- Specify - Unsettled
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.
No
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
Pet-owner took the dog to the emergency clinic for vitals check. (No comment on the vitals observed).
The dog was bathed twice, the symptoms lasted about 72 hours, and the pet-owner was concerned with the dogas behaviour. The dog is now 100 % recovered as of June 19, 2023.
The dog was sent home with another flea/tick prevention product.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here