Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2887
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_001197
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.
26-APR-24
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
12-APR-24
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 26Apr2024, a pet owner contacted Elanco to report an adverse reaction with K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 12Apr2024, the pet owner applied 1 tube of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) to the dog. The product was used correctly. No concomitant products were administered.
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
crossbred Maltese/ Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
4
7. Weight (provide a range if necessary )
3.2
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Nervous and Muscular Systems
- Skin
- Symptom - Lesion
- Specify - Application site scab
- Symptom - Pruritus
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?
Yes
14. b) How long was the animal hospitalized?
Unknown
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 12Apr2024, immediately after application, the 4 year old, 3.2 kg, neutered male, crossbred Maltese/Yorkshire dog developed application site pruritus. On 15Apr2024 the dog was disoriented, the sign lasted 10 minutes, and the dog recovered without treatment. On 18Apr2024 the dog was seen by the veterinarian and kept at the veterinary clinic for a few hours for observation. No abnormalities were noted and no treatments were administered. Upon arriving home the dog became disoriented. The sign lasted 25 minutes and the dog recovered without treatment. On 19Apr2024, the dog was seen by the veterinarian. A full blood test and urinalysis was performed and the results were all within normal limits. The owner noticed an application site scab. The dog was not treated. The outcome of this case is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here