Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-2574

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0015474 (Report 696381)

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.

20-APR-21

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9 Advantix II pipette size unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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7. b) Type of formulation.

Other (specify)

Spot-on

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 an unspecified date in 2017, a 7.5 year old, of unknown weight, neutered, female, Airedale Terrier canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Airedale Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

Unknown

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

• Nervous and Muscular Systems
  • Symptom - Head shaking

• General
  • Symptom - Abnormal behaviour
  • Symptom - Fever

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Other
  • Specify - Lyme Disease
  • Symptom - Death

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

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 an unspecified date in 2017, the dog was shaking her head and not acting right (behavior disorder NOS). The dog was examined by a veterinarian and had a fever. The dog tested positive for Lyme disease on an unspecified test. Unspecified medications were administered. On an unspecified date in 2017, the dog was anorexic, adipsic and died. No necropsy was performed. No further information is expected. The case is closed. Note: The intent of the call was to inquire about product use in general and not to report this event.

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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

O - Unclassifiable/unassessable Reported behavioural disorders are very unspecific signs and may have other numerous causes. Reported fever followed by adipsia and off food may be associated with diagnosed Lyme's disease. No ticks were reported and thus it is unclear when the dog contracted the Lyme disease. Moreover, Lyme disease has a long incubation period (1-5 months), therefore the animal could have contracted the disease before product application. Death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Sign might be a consequence of the Lyme's disease or other etiologies are possible as well. No signs of allergy/anaphylactic reaction reported. Exact time to onset is unknown. Considering all aspects, product involvement is unassessable.