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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-6353
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2021_000859
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
09-SEP-215. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
25-JUL-21Product 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. PMRA Submission No. EPA Registration No. Unknown
Product Name: K9 advantix II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 9-Sep-2021 a hospital staff member advised Elanco of an adverse reaction and a suspected lack of efficacy to K9 advantix II pipette size unknown (Permethrin, Imidacloprid). On 29-Apr-2021, 18-Jun-2021, 18-Jul-2021, and 8-Aug-2021 a 12.6 year old, 5.81kg, neutered, male, Shih Tzu canine/dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 advantix II pipette size unknown (Permethrin, Imidacloprid) topically by the owner on.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Shih Tzu
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12.6
7. Weight (provide a range if necessary )
5.8
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
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- General
- Symptom - Lethargy
- Nervous and Muscular Systems
- Symptom - Anxiety
- Ear
- Symptom - Other
- Specify - More reactive to noise
- Skin
- Symptom - Erythema
- General
- Symptom - Parasitism
- Ear
- Symptom - Other
- Specify - Yeast
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?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
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 approximately 25-Jul-2021 the dog developed generalized pruritus and was lethargic. On 7-Aug-2021 the pet owner saw one live flea on the dog. On approximately 23-Aug-2021 the pet owner saw another live flea on her dog. On 26-Aug-2021 the dog was seen by a veterinarian and found to be more anxious, and more reactive to noise. The veterinarian did not find any signs of flea dirt. The dog had moderate erythema on the ventral abdomen, and interdigital erythema on the 4 paws. Ear and skin cytology was performed. Skin cytology was negative, ear cytology confirmed yeast in the left ear. The dog was prescribed Apoquel, Douxo Calm shampoo, and Nexgard. outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
