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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-5773
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2022_001519
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.
15-AUG-225. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
27-JUN-22Product 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 15-Aug-2022, a clinic staff member contacted Elanco regarding adverse event following the application of K9 Advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen). On 27-Jun-2022 the pet owner applied the K9 Advantix II 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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
German Short-Haired Pointer
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7.5
7. Weight (provide a range if necessary )
32
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Lesion
- Symptom - Other
- Specify - Purulent discharge
- Symptom - Pruritus
- Symptom - Lesion
- Specify - Skin scab
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
Fully Recovered / Complètement 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 27-Jun-2022, an unknown time after application, the 7.5 year old, 32kg, neutered, male, German Short-Haired Pointing dog, in unknown condition, with concomitant medical conditions of uncontrolled Addison's disease, being administered fludrocortisone (both generic and branded) since 01Sep2021, developed pruritus and hair loss. It is unknown if the pruritus and hair loss were at the application site or generalized. On 02-Jul-2022 the dog was seen by the veterinary clinic and the dog had a wound between the shoulder blades, unknown if this is at the application site, which was shaved and cleaned with an unspecified cleaner and the dog was prescribed a Triamcinolone, Neomycin, Gramicidin, and Nystatin cream. On 04-Jul-2022 the dog was seen by the veterinarian and the wound was now purulent and scabbed over. The dog was given an injection of Cefovecin sodium sterile injectable lyophile and was prescribed a corticosteroid. On 08-Jul-2022 the wound had resolved and the dog had recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
