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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5450

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0048185 (Report 665541)

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.

15-SEP-20

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto collar Cat

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: COLLAR

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 approximately 15-Jun-2020, a 12 year old, female cat, of unknown breed and weight, in unknown condition, with a concomitant medical condition of diabetes, had one Seresto Cat collar(Flumethrin-Imidacloprid) placed around the neck by the animal owner. The cat was administered 0.5 international units of unspecified insulin twice daily by the animal owner. On an unspecified date in approximately Jul-2020, the cat was administered 1 international unit of unspecified insulin via the subcutaneous route by the animal owner.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12

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

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Death
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Respiratory System
    • Symptom - Difficulty Breathing
  • General
    • Symptom - Other
    • Specify - Loose teeth

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 in approximately Jun-2020, the cat developed generalized pruritus, loose teeth and was bathed with liquid dish detergent. On an unspecified date in approximately Jul-2020, the cat was administered 1 international unit of unspecified insulin via the subcutaneous route by the animal owner. Approximately 12 hours later on an unspecified date in approximately Jul-2020, the cat began vocalizing, had a grand mal seizure, breathing difficulty and died.


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 Pruritus on other than the application site is not typically seen with topical product administratio. Reported loose teeth is not expected after product application. However, the cat is a geriatric and diabetic patient, which may contribute to signs. The product is not anticipated to cause serious neurological disorders such as grand mal seizure after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures were reported in connection with product use in dogs. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Reported vocalisation and breathing difficulty may be associated with reported grand mal seizure. Further reported death is not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Additionally the intent of the call was not to report this event but to raise questions concerning the product (e.g. mode of action) and apparently did not see a relation between product use and the sign reported. Although no necropsy performed, product involvement is not likely however due to limited information case is considered unassessable.