Incident Report
Subform I: General Information
1. Report Type.
Update the report
Incident Report Number: 2023-5713
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001538
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.
26-JUL-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
Unknown
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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
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 26-Jul-2023, a pet owner contacted Elanco regarding a possible adverse reaction to K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 01-Apr-2023 the pet owner applied the product to the dog. The product was used correctly. The pet owner continued to apply the K9 Advantix II monthly, and was last applied on 01-Jul-2023. For the past 5 years the dog has also been taking a daily joint supplement.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Labrador Retriever/Collie crossbred dog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
15
7. Weight (provide a range if necessary )
29
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
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Hair loss
- Symptom - Red skin
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
An unknown time after application, the 15 year old, 29kg, neutered, female, Labrador Retriever/Collie crossbred dog began scratching/ chewing (pruritus) at her back legs, hind end, and tail. On an unknown date, the pet owner started the dog on an oral probiotic. The signs continued. On 25-Jul-2023 the dog was seen by a veterinarian. The veterinarian found the dog to have hair loss on the hind limbs and reddening of the skin on the hind limbs. The veterinarian performed a skin scraping, which revealed no abnormal findings, and tested the dog for ringworm. The dog was negative for ringworm. The dog was prescribed fluralaner, cephalexin, prednisone, and a chlorhexidine shampoo. On 18-Sep-2023 the pet owner reported that the dog had hair loss along her back. It is unknown if the hairloss is at the application sites.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here