Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0357

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0061043 (Report 679041)

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

02-DEC-20

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

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: Advantage Spot-on pipette size unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %

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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 approximately 2009, a female, Siamese feline, of unknown age and weight, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (cat-unspecified) (Imidacloprid) topically by the owner. The cat continued to have the product applied monthly.

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

Cat / Chat

3. Breed

Siamese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

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 - Bizarre behaviour

• General
  • Symptom - Death
  • Symptom - Parasitism
  • Specify - fleas

12. How long did the symptoms last?

Unknown / Inconnu

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 an unspecified date post application, in 2009, the cat had visible fleas. On an unspecified date post application in 2009, the cat continued to have visible fleas and exhibited a behavior change. The product administration was discontinued and it was unknown if the cat was examined by a veterinarian. On an unspecified date in 2009, post application, the cat died. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will such be sought. No more information is expected and this case is closed.

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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 SLEE/fleas. Presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Unknown if re-infestation from infested environment (e.g. by means of other untreated animals, wildlife) occurred. Unknown if environment was treated to stop re-infestation via emerging pupae that are still present in the environment. Moreover, in this case, product was applied previously however exact dates, duration of treatment and duration of flea infestaion are unknown. Further, potential contributing factors including environmental infestation pressure not clarified. Reported behavioral sign is unspecific and in this case rather associated with current flea infestation. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Considering limited information such as medical history, health status, time to onset and necropsy details, a product involvement is unassessable.