Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-0770
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2021_042301
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 1919 Minnesota Court, Suite 401
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L59 0C9
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
14-DEC-21
5. Location of incident.
Country: UNITED STATES
Prov / State: MICHIGAN
6. Date incident was first observed.
14-JAN-21
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 14-Dec-2021, Elanco was contacted by an animal owner regarding the use of K9 Advantix II Extra Large Dog (Over 55 lbs). On approximately 14-Dec-2020, the dog was administered 1 tube of K9 Advantix II Extra Large Dog (Over 55 lbs) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner. It is unknown if 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?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Unknown (Canine/dog)
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Neoplasia
- Symptom - Cancer
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 approximately 14-Jan-2021, the dog, of unknown signalment, in unknown condition, with no known concomitant medical conditions, developed a hemangiosarcoma and died. The dog was not evaluated by a veterinarian
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here