Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2218
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2024_009417
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-MAR-24
5. Location of incident.
Country: UNITED STATES
Prov / State: PENNSYLVANIA
6. Date incident was first observed.
09-MAR-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.
PMRA Submission No.
EPA Registration No. 11556-133
Product Name: K9 Advantix Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 09 Mar 2024, Elanco received a communication from an animal owner regarding an adverse event involving K9 Advantix Medium Dog on a canine. On 09 Mar 2024, 1 tube/pipette of K9 Advantix Medium Dog was administeredto a canine topically by the animal owner for flea control. This product has been used sporadically on this pet since approximately 2022 with no issues.
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
Maltese
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
16
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- General
- Symptom - Pacing
- Symptom - Polydipsia
- General
- Symptom - Listless
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
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 09 Mar 2024, 30 minutes post application, the 16-year-old, neutered male, Maltese dog, of an unknown weight and reproductive status, in unknown condition, with unknown concomitant medical conditions, exhibited diarrhoea, reddening of the skin, drinking a lot, and pacing. The canine was not examined by a veterinarian. The canine was bathed with baby shampoo and few times with a liquid dish soap and dried him off. On 10 Mar 2024 morning, the dog was listless, and his eyes were glazed over. On 10 Mar 2024 at approximately 9:30am, the pet died at home. Veterinarian attention was not sought, and owner plans to have the pet cremated.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here