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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4676
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001232
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.
23-JUN-235. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
12-APR-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. 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.
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 23 Jun 2023 the clinic's staff contacted Elanco regarding a possible adverse reaction involving K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 100 (Imidacloprid, Moxidectin). On 12 Apr 2023, 12 May 2023, and 12 Jun 2023, the owner applied a tube of K9 Advantix II Extra Large Dog to the dog. On 03 Jun 2023 the pet owner applied a tube of Advantage Multi 100.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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Retriever - Labrador
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
33.6
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 / <=30 min
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Gastrointestinal System
- Symptom - Diarrhea
- General
- Symptom - Lethargy
- Symptom - Parasitism
- Specify - Ehrlichia
12. How long did the symptoms last?
Unknown / Inconnu
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
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 12 Apr 2023, immediately post application, the 11 year old, 33.6 kg, neutered female Labrador Retriever dog, who had a negative SNAP 4 dx test on 01Apr2023, had application site pruritus. The pet owner bathed the dog with an unknown shampoo the same day. Pruritus resolved on an unknown date. On 12 May 2023 immediately after application the dog had application site pruritus. The pet owner bathed the dog with an unknown shampoo the same day. Pruritus resolved on an unknown date. On 04 Jun 2023 the dog developed diarrhoea. On 12 Jun 2023, immediately after application, the dog had application site pruritus. The pet owner bathed the dog with an unknown shampoo the same day. Pruritus resolved on an unknown date. On 20 Jun 2023 the dog was examined by the veterinarian due to lethargy and ongoing diarrhoea. A SNAP 4 dx test was positive for ehrlichia although a tick had never been found on the dog. No treatment was prescribed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
