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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-4933
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2022_001321
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.
20-JUL-225. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
20-JUL-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. 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 20 Jul 2022 a pet owner contacted an emergency call center and reported an adverse reaction involving K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) in a dog. On 20-Jul-2022, a dog was administered 1 tube of K9 Advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) via the topical route by the animal owner. This was the first use of the product and it was being used for ectoparasite protection. No other veterinary medical products were administered.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
Bichon Frise dog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
13
7. Weight (provide a range if necessary )
4.5
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
<=30 min / <=30 min
11. List all symptoms
System
- Skin
- Symptom - Itchy skin
- Nervous and Muscular Systems
- Symptom - Head shaking
- General
- Symptom - Licking
- Nervous and Muscular Systems
- Symptom - Restlessness
- Skin
- 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
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 20-Jul-2022, 15 minutes after application, the 13 year old, 4.5 kilogram, neutered, male, Bichon Frise dog, in unknown condition, with no known concomitant medical conditions, began scratching at the application site (itchy skin), was itchy at the application site, and was shaking his head. The signs persisted through the night. On 21 Jul 2022 the application site scratching and application site itching resolved, but the head shaking persisted. The dog also started licking his paws and was restless. On approximately 26 Jul 2022 the pet owner noted scabbing at the application site. On 04 Aug 2022 the dog was seen by a veterinarian who prescribed Surolan to be applied to the affected area for 1 week. On 08 Aug 2022 the pet owner reported the dog was improving but not recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
