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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4333
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_000930
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.
24-MAY-235. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
21-MAY-23Product 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.
.4Units: 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 24-May-2023, a pet owner contacted Elanco regarding a possible adverse reaction to K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 20-May-2023 the pet owner applied the product to the dog.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
crossbred Yorkshire terrier/ Maltese
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.75
7. Weight (provide a range if necessary )
3.7
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Bloody diarrhea
- Symptom - Vomiting
- General
- Symptom - Lethargy
- Gastrointestinal System
- Symptom - Anorexia
- Symptom - Other
- Specify - Gastroenteritis
- Liver
- Symptom - Elevated liver enzymes
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Not recovered / Non rétabli
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 21-May-2023, the 0.75 year old, 3.7kg, intact, female, Yorkshire Terrier/Maltese crossbred dog vomited, had bloody diarrhea, was lethargic, and anorexic. On 21-May-2023 the dog was seen by a veterinarian at an emergency veterinary clinic. The veterinarian suspected the dog had gastroenteritis and the dog was given an injection of Maropitant, an injection of Famotidine, and a prescription of Maropitant, Metronidazole, and Omeprazole. On 22-May-2023 the diarrhea became more haemorrhagic. On 23-May-2023 the dog was seen by her family veterinarian. Blood work was done, including a Snap 4DX, and the serum alkaline phosphotase was slightly elevated (elevated liver enzymes), the rest of the blood results were within normal limits, and the Snap 4DX was negative. Radiographs were also performed but results of the findings were not provided. The dog was given subcutaneous fluids, an injection of Famotidine, was prescribed Gabapentin, a probiotic and a gastrointestinal food.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
