Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4987
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001251
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.
26-JUN-23
5. Location of incident.
Country: CANADA
Prov / State: NEWFOUNDLAND
6. Date incident was first observed.
22-JUN-23
Product 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.
.4
Units: 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 26-Jun-2023 a pet owner contacted Elanco to report a possible adverse event regarding K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On 22-Jun-2023, a dog was administered 1 tube of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner along the dorsal midline.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Maltese x Yorkshire Terrier crossbred
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.7
7. Weight (provide a range if necessary )
1.9
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Specify - Circling
- Skin
- Symptom - Lesion
- Symptom - Pruritus
- Specify - Self trauma
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
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 22-Jun-2023, 30 minutes following application, the 8.5 month old, 1.9 kg, intact, male, Maltese x Yorkshire Terrier crossbred dog, in good condition, with no known concomitant medical conditions, began to itch at the application site and was circling. On 25-Jun-2023 the owner noticed the dog had caused some self trauma to the application site creating a wound (lesion). On 26-Jun-2023 the dog was examined by a DVM. The dog was no longer circling. The dog was prescribed Fusidic acid (as fusidic acid hemihydrate) 0.5% w/w Betamethasone (as betamethasone valerate) 0.1% w/w gel. On 28-Jun-2023 the clinic reported the dog was no longer itchy at the application site.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here