Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-3995
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_000982 and CA2023_000984
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.
29-MAY-23
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
28-MAY-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. 29778
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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 29-May-2023 a veterinarian contacted Elanco to report possible adverse events regarding K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 28-May-2023, two dogs each were administered 1 tube of K9 advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner along the dorsal midline.
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
Dog / Chien
3. Breed
Maltese
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
4.5
7. Weight (provide a range if necessary )
4.2
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Agitation
- Symptom - Muscle twitching
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 28-May-2023, 8 hours post application, the 4.5 year old, 4.2 kg, neutered, male, Maltese canine/dog, in good condition, with no known concomitant medical conditions conditions, experienced twitching and zingy/agitated. The owner contacted an emergency clinic, and was directed to give all the dogs a cool-water bath but owner chose not to bathe. On 29-May-2023, the dog recovered from the twitching and zingy/agitation but was lethargic.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Maltese crossbred
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
7.75
7. Weight (provide a range if necessary )
4.2
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Muscle twitching
- Symptom - Agitation
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
8 hours following the application the owner reported the 7.75 year old, 4.2 kg, neutered, female, Maltese crossbred dog, in good condition, with no known concomitant medical conditions, was twitching and zingy/agitated. The owner contacted an emergency clinic, and was directed to give all the dogs a cool-water bath but owner chose not to bathe. On 29-May-2023, the owner reported the dog recovered from the twitching and zingy/agitation but was lethargic.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here