Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5722
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2023_001581
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.
27-JUL-23
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
26-JUL-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.
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 27-Jul-2023, a veterinary clinic reported a possible adverse event through Bayer SafeTrack, which was forward to Elanco, regarding K9 advantix II pipette size unknown (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On 26-Jul-2023, a dog was administered 1 tube of K9 advantix II pipette size unknown (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner. The dog used K9 Advantix II monthly for the last 5 years.
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
Terrier - Rat
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 yr / > 1 an
10. Time between exposure and onset of symptoms
>6 mos / > 6 mois
11. List all symptoms
System
- Skin
- Symptom - Rash
- Symptom - Pruritus
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 26 Jul 2023, an unknown time after application of K9 Advantix II, the neutered, female, Rat Terrier dog, of unknown age and weight, in unknown condition, with unknown concomitant medical conditions, developed a pruritic rash. On 27 Jul 2023 the dog was examined by a veterinarian. The site of the rash was cleaned with chlorhexidine soap and treated with Vitamin E cream.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here