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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-5915
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2022_001587
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.
22-AUG-225. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
26-MAY-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 22-Aug-2022 an RVT contacted Elanco to report a possible adverse event regarding K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On 25-May-2022, a dog was administered 1 tube of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner along the dorsal midline. On 25-Jun-2022, the owner applied 1 tube of K9 advantix II small dog. On 25-Jul-2022 the owner applied 1 tube of K9 advantix II Small 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
Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
3.3
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Ataxia
- General
- Symptom - Lethargy
- Nervous and Muscular Systems
- Symptom - Shaking
- Symptom - Ataxia
- Specify - Falling
- Symptom - Difficulty walking
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
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 26-May-2022, the 7 year old, 3.3 kg, neutered, male, Yorkshire Terrier dog, in good condition, with no known concomitant medical conditions, with a history of previous vaccine reactions, who had anal glands expressed and normal bloodwork values on an unknown date prior to the May application of K9 Advantix II, fell off the couch, was lethargic, wobbly (ataxia), and shaking. On 27-May-2022 the dog recovered. The owner did not recall the dog having an adverse event after the 25Jun2022 application. On 26-Jul-2022 the dog became lethargic, wobbly and shaking. On 27-Jul-2022 the dog recovered. On 24-Aug-2022 the clinic spoke with the pet owner and they decided to do a re-challenge with a new box of K9 advantix II Small dog.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
