Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5407

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0038142 (Report 655172)

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.

28-JUL-20

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

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. 11556-155

Product Name: Seresto cat

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

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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 25Jul2020, a 20 week old, 6 pound, intact, male, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around his neck by the 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.41

7. Weight (provide a range if necessary )

2.722

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• Skin
  • Symptom - Inflammation of the skin

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Respiratory distress

• Gastrointestinal System
  • Symptom - Oral hemorrhage

• Skin
  • Symptom - Other
  • Specify - ligature furrow at the collar site of the neck

• Respiratory System
  • Symptom - Chest congestion
  • Symptom - Other
  • Specify - Red froth in the trachea
  • Symptom - Pulmonary edema

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 28Jul2020, the feline was found deceased with the Seresto collar caught around the lower jaw. The feline also had vomited once and exhibited facial swelling. The feline was taken to the veterinary clinic. No necropsy examination had been performed. On 29Jul2020, a necropsy examination was performed. The collar was in a taut loop around the lateral and dorsal aspects of the neck and caught in the mouth under the tongue. The mandible was reflected caudodorsally by the collar and the jaw remained fixed in position when the collar was removed. There was a small amount of blood in the mouth and on the periorbital hair. There was a ligature furrow at the collar site of the neck (application site skin change NOS). The lungs were markedly congested and mildly to moderate edematous. Red froth was located in the trachea. Histological examination of the lungs revealed congested blood vessels and alveolar spaces multifocally contained free erythrocytes and small amounts of acidophilic proteinaceous material. There were no significant findings on aerobic culture of colon, liver, lung and small intestine tissues. Diagnosis was ligature strangulation (asphyxia) and pulmonary congestion and edema.

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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

No assessment performed This case is a duplicate of USA-BAYERBAH-2020-US0037486 and is being nullified and change to an Inquiry / Info only case.