Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-3719
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2022_018551
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.
09-MAY-22
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
28-APR-22
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.
PMRA Submission No.
EPA Registration No. 11556-144
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
7. b) Type of formulation.
Liquid
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 9 May 2022, an animal owner contacted Elanco regarding a potential adverse event with using K9 Advantix II Extra Large Dog on their canine and reported the following: On 25Apr2022, the dog was administered 1 tube of K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen), topically, by the owner for tick control. No concomitant products were administered.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
crossbreed
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
4
7. Weight (provide a range if necessary )
22.7
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Vocalizing
- Symptom - Hiding
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
Died
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 28Apr2022, the approximately 4 to 5-year-old, 22.7-27.2 kg, neutered female, crossbreed canine, in unknown condition, with no known concomitant medical conditions, exhibited a single episode of vomiting. On 01May2022, the canine was hiding under a deck, vocalizing, and died. The canine was not examined by a veterinarian and no necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here