Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4974
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001185
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.
19-JUN-23
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
08-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. 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.
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 19 Jun 2023, the clinic staff contacted Elanco to report a possible adverse reaction involving K9 advantix II Extra Large Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 100 (Imidacloprid, Moxidectin) in a dog. On 8 Jun 2023, the patient was treated topically with a pipette of K9 advantix II for the first time. On 15 Jun 2023, the patient was treated topically with a pipette of Advantage Multi 100.
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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
crossbred Golden Retriever X Poodle dog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1.25
7. Weight (provide a range if necessary )
31.81
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
- Gastrointestinal System
- Symptom - Other
- Specify - Eructation
- Nervous and Muscular Systems
- Gastrointestinal System
- Symptom - Nausea
- Symptom - Other
- Specify - Gastric reflux
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 8 Jun 2023, an unknown time after application, the 15 month old, 31.81 kg, neutered male, Golden Retriever X Poodle dog, in good condition, with no concomitant medication or prior medical history, developed scratching (pruritus) at the K9 Advantix II application site. On 15 Jun 2023, the dog developed gastric reflux, burping (eructation), nausea and lethargy. On 18 Jun 2023, the patient was examined by a veterinarian and had generalized pruritus, erythema and a skin lesion in the perineal region. The pet owner also reported agitation and biting of the paws (pruritus). The gastric reflux, burping, nausea and lethargy had resolved. Treatment consisted of washing the application site with dish soap, a shampoo and trimeprazine tartrate with prednisolone.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here