Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5711
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001518
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-JUL-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
23-JUN-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. 29780
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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-Jul-2023, a clinic staff member contacted Elanco regarding a possible adverse reaction to K9 advantix II Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 21-Jun-2023 and 20 Jul 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?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
French Bulldog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1.25
7. Weight (provide a range if necessary )
13.3
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Skin
- Symptom - Inflammation of the skin
- Symptom - Red skin
- Symptom - Hair loss
- Symptom - Lesion
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 23-Jun-2023, the 1.25 year old, 13.3 kg, intact, male, French Bulldog experienced application site redness, application site inflammation, application site hair loss, and an application site lesion. An unknown time after onset, all signs had resolved without treatment. On 22-Jul-2023 the dog again experienced application site redness, application site inflammation, and application site lesion. On 25-Jul-2023 the dog was seen by the veterinarian and the affected area was shaved, cleaned with chlorhexidine, and the dog was prescribed a Fusidic acid, Betamethasone, topical antibiotic/corticosteroid gel.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here