Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5782

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2022_001567

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.

18-AUG-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-JUN-22

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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Small 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.

.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 18-Aug-2022 a veterinary hospital contacted Elanco to report a possible adverse event regarding K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) and Advantage Multi 10 (Imidacloprid, Moxidectin) concerning a dog. On 18-Jun-2022 and 15-Jul-2022 1 tube of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) and 1 tube of Advantage Multi 10 (Imidacloprid, Moxidectin) topically by the owner along the dorsal midline. On 15-Aug-2022, a dog was administered 1 tube of K9 advantix II Small Dog (Permethrin, Imidacloprid, Pyriproxyfen) topically by the owner along the dorsal midline. On 15-Aug-2022 the canine/dog was also administered 1 tube of Advantage Multi 10 (Imidacloprid, Moxidectin) 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

3.2

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

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Pruritus
  • Symptom - Red skin

• General
  • Symptom - Swelling

• Skin
  • Symptom - Erythema

• General
  • Symptom - Licking

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 19-Jun-2022 and 16-Jul-2022 the 2 year old, 3.2 kg, neutered, female, Chihuahua dog, in good condition, with no known concomitant medical conditions, developed generalized pruritus, swollen, erythemic feet and began to lick them but did not report to veterinarian. It was unknown when the symptoms resolved. On 18-Aug-2022, the dog developed generalized pruritus, swollen, erythemic feet and began to lick them. On 18-Aug-2022 the owner was dispensed diphenhydramine. On 20-Aug-2022 the dog was examined by DVM and was dispensed Isaderm gel for the dogs feet. Dermallay Shampoo and Conditioner but unknow if dog has been bathed with it yet.

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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