Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2215
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2023_063038
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.
25-NOV-23
5. Location of incident.
Country: UNITED STATES
Prov / State: NEW YORK
6. Date incident was first observed.
25-NOV-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.
PMRA Submission No.
EPA Registration No. 11556-142
Product Name: K9 Advantix II Medium 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.
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 25 Nov 2023, Elanco was contacted by an animal owner regarding a possible adverse event when using K9 Advantix II Medium Dog and reported the following: On 25-Nov-2023, a dog was administered with 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) via a topical route by the animal owner for flea and tick prevention. K9 Advantix has been used on this pet monthly for many years on an unspecified date and had no reaction to the product in past. On 25 Nov 2023, the dog was also administered an unknown dose of Maropitant Citrate via an oral route, unknown of levothyroxine Sodium via an oral route, an unknown dose of Pimobendan via an oral route, omeprazole and prednisone via an oral route by the animal owner and by the animal owner. On 08 Mar 2024, the owner called Elanco with more information.
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
Havanese/Poodle (Unspecified) crossbred
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
17
7. Weight (provide a range if necessary )
7.7
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
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
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
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 25Nov2023, the owner reported the following to Elanco: On 25-Nov-2023, approximately 2 hours post application, the 17-year-old, 7.7 kg, neutered, male, Havanese/Poodle (Unspecified) crossbred dog, in an unknown condition, with concomitant medical conditions of Thyroid disease, unspecified gastrointestinal issues, and unspecified heart issues, began shaking. The pet was bathed by the owner and was resting comfortably. It was unknown what the pet was bathed with. Pet has a history of shaking episodes when he needs to be fed. Pet did have a medication change recently so pet owner is trying to rule out the cause of symptoms. On 08Mar2024, the owner reporting the following to Elanco: On an unknown date, the dog died.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here