Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6985

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_002104

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.

15-SEP-23

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

11-SEP-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)

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PMRA Registration No. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Medium Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 15-Sep-2023 a pet owner contacted Elanco to report a possible adverse event regarding K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) concerning a dog. On 10-Sep-2023, a dog had 1 tube of K9 Advantix II Medium Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner.

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

Bichon Frise crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

6.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Skin
  • Symptom - Blister
  • Symptom - Other
  • Specify - Mucopurulent discharge
  • Symptom - Dermatitis
  • Specify - Crust

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 11-Sep-2023, the 13-year-old, 6.8 kg, neutered, female, Bichon Frise crossbred dog, in unknown condition, with no known concomitant medical conditions, had area of application site blistered. On 12-Sep-2023 the owner noted there was mucopurulent discharge where there were blisters. On 15-Sep-2023 the application site was crusted with dried pus. On 16-Sep-2023 the dog was examined by a DVM. The application site area was clipped and cleaned and the dog was prescribed Fusidic acid (as fusidic acid hemihydrate) 0.5% w/w, Betamethasone (as betamethasone valerate) 0.1% w/w gel. On 19-Sep-2023 the owner reported the dog was doing well and the wound was healing.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here