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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0108

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2021_001078

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.

08-OCT-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

04-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)

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 08 Oct 2021 a veterinary technician informed Elanco of an adverse event to Advantage Multi 100 (Imidacloprid, Moxidectin) in a dog. On 18-Sep-2021, the dog, in unknown condition, with concomitant medical conditions of dry skin, hair loss, itchy, fleas, otitis externa, and diagnosed with demodectic mange, was administered 1 tube of Advantage Multi 100 (Imidacloprid, Moxidectin) topically by the owner. The dog received an unknown dose of K9 Advantix II on an unknown date. The dog was also prescribed 1.5 tablets clavasceptin 250 mg every 12 hours for 15 days. On 25 Sep 2021 the dog was administered another dose of Advantage Multi 100 (Imidacloprid, Moxidectin) topically by animal owner. On 02 Oct 2021 the dog received another dose of Advantage Multi 100 (Imidacloprid, Moxidectin) topically by animal owner (misuse type: high frequency as this product is labeled for monthly use).

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

German Shepherd Dog / Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

27.7

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Loss of balance
  • Gastrointestinal System
    • Symptom - Weight loss
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • General
    • Symptom - Pale mucous membrane colour
  • Skin
    • Symptom - Bruises
  • General
    • Symptom - Swelling
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Blistering in the mouth
    • Symptom - Drooling
  • Blood
    • Symptom - Leukocytosis
    • Symptom - Other
    • Specify - Lymphocytosis
    • Symptom - Anemia
    • Symptom - Thrombocytopenia
    • Symptom - Hyperglycemia
    • Symptom - Hypoproteinemia
    • Symptom - Hypoalbuminemia
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Retroperitoneal hemorrhage
  • Blood
    • Symptom - Abnormal coagulation
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Fell off couch and got leg stuck
  • Blood
    • Symptom - Hyperbilirubinemia

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

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 04 Oct 2021 the a 3 year old, 27.7 kilogram, female, Shepherd Dog - German crossbred canine, fell off the couch and got its leg stuck. On 06 Oct 2021 the dog presented to a veterinarian and had weight loss (now weighed 23 kilograms), was recumbent, was pale, had bruising and swelling of the hindlimbs, blisters in the mouth, and was drooling. Bloodwork revealed elevated white blood cell count, elevated neutrophils, elevated lymphocytes, severe anemia (hematocrit 14%), low red blood cell count (1.93 and normal 5.5- 8.5), low hemoglobin, low normal platelets (101), elevated total bilirubin 15, normal 2- 10), elevated glucose (8.1, normal 3.3- 6.1), low total protein (49, normal 54- 82), low albumin (23, normal > 25). A coagulation panel revealed the dog had elevated fibrinogen (6.2 normal 1- 4), increased prothrombin time 60 (normal 6.3- 13.3) and partial thromboplastin time was greater than 120 (normal 10.6- 16.8). Units for these ranges were not provided, and the medical records have not been received. On 07 Oct 2021 the dog was found dead. A post mortem performed in clinic found retroperitoneal hemorrhage. The veterinarian suspected the dog died from bleeding out.


To be determined by Registrant

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

Death

19. Provide supplemental information here