Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0170

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2021_001237

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4T2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-OCT-21

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

20-OCT-21

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. 27583      PMRA Submission No.       EPA Registration No. 11556-125

Product Name: Advantage II Medium Dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • 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 27 Oct 2021 a pet owner informed Elanco of an adverse reaction to Advantage II Medium Dog (Imidacloprid, Pyriproxyfen) in a canine/ dog. The pet owner also made a product complaint involving this product and this report serves as the product complaint report. On 19-Oct-2021, the dog was administered 1 tube of Advantage II Medium Dog (Imidacloprid, Pyriproxyfen) (lot number KV029AL/ KP0F8BP) topically by the owner (misuse: underdose). The dog has had this product in the past without issue

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Beagle / Blue Heeler

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

31.8

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Paralysis

• General
  • Symptom - Lethargy
  • Symptom - Abnormal behaviour
  • Symptom - Hesitancy to move

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 20 Oct 2021, the 10 year old, 31.8 kilogram, unknown reproductive status, female, Beagle/Blue Heeler canine/dog, in unknown condition, with unknown concomitant medical conditions, was not moving as much, but this was not unusual for her. The dog was also acting unusual. On 21 Oct 2021 the dog began vomiting and could not move. On 22 Oct 2021 the dog was paralyzed and unable to move. On 23 Oct 2021 the dog died. On 27 Oct 2021 the pet owner contacted Elanco and was concerned there was a problem with this lot (product complaint/ product defect). A necropsy was offered and declined as the dog had been cremated.

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To be determined by Registrant

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

Death

19. Provide supplemental information here