Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4871
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001027
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.
05-JUN-23
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
04-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. 29777
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Small Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- 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 5 Jun 2023, an animal owner contacted Elanco's after hours service regarding a possible adverse effect involving Advantage Multi 10 (Imidacloprid, Moxidectin) and K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) in dog. On 2 Jun 2023, the owner applied one tube of Advantage Multi 10 to the dog. On 4 Jun 2023, the owner applied one tube of K9 Advantix ll Small Dog to the dog.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Maltese
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
3.6
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>15 min <=2 hrs / >15 min <=2 h
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Restlessness
- Symptom - Muscle twitching
- Nervous and Muscular Systems
- General
- Symptom - Licking
- Symptom - Abnormal behaviour
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
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
Approximately two hours after application, the 9 year old, 3.6 kg, neutered female Maltese dog was twitching, jumping up (restlessness), throwing its head back (head shaking), licking the air, and had red skin at the application site. The pet owner bathed the dog three times with a stripping shampoo. Two hours later the pet owner reported the dog was relaxed, and no longer showing the twitching or restless behaviour. On 5 Jun 2023 the pet owner reported the dog was completely recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here