Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-5321
2. Registrant Information.
Registrant Reference Number: 34210
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
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.
12-AUG-20
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
07-AUG-20
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. 29780
PMRA Submission No.
EPA Registration No.
Product Name: k9 advantix II large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- 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 6-Aug-2020, a 14 year old, 22 kg, male neutered Australian Shepherd Dog in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 2 X 2.5 ML LGE DOG, (-), by Animal owner. The product was used according to label (Yes).
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
Australian Shepherd
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
14
7. Weight (provide a range if necessary )
22
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
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
- Respiratory System
- Symptom - Other
- Specify - Shallow breathing
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
On 07-Aug-2020 ~12 hours after application the became lethargic, ataxic and had shallow breathing. Within 36 hours the dog returned to normal on 9-Aug-2020.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here