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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0340

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0060915 (Report 678762)

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.

01-DEC-20

5. Location of incident.

Country: UNITED STATES

Prov / State: WISCONSIN

6. Date incident was first observed.

01-JUL-20

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 Small Dog

  • Active Ingredient(s)
    • 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 01-Mar-2020, an approximately 8 week old, intact, male, Spitz - German Pomeranian dog, of unknown weight, in unknown condition, with a concomitant medical condition of fleas, had one Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal 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

German Spitz - Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.153

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Weakness
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Appetite disorder NOS
  • Respiratory System
    • Symptom - Other
    • Specify - Respiratory arrest
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • General
    • Symptom - Other
    • Specify - Exercise intolerance
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Respiratory System
    • Symptom - Dyspnea

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 unknown date post application in approximately Mar-2020, the concomitant fleas resolved. On approximately 01-Jul-2020, the dog exhibited lethargy, fluctuations in appetite, exercise intolerance, weakness, and lateral recumbency. On an unknown date post onset clinical signs in 2020, the dog was evaluated by a veterinarian and no treatments were performed. On approximately 02-Nov-2020, the collar was removed and the now 1 year old, 15 pound, intact, male, Spitz - German Pomeranian dog, had one Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On approximately 16-Nov-2020, the lethargy worsened. On 26-Nov-2020, the dog exhibited dyspnea. On 29-Nov-2020, the dog was found laying in the snow and exhibited dyspnea, respiratory arrest, and the dog died. No necropsy was performed.


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 lethargy, fluctuations in appetite, exercise intolerance and weakness are unspecific and may have numerous other causes. Further, lateral recumbency, dyspnoea, laying in the snow, respiratory arrest and death of the dog are not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Oral exposure to the collar is not expected to cause such signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing 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. However, in this case young animal with unknown health status may have died due to respiratory disorders. Time to onset is long. No necropsy was performed. Overall, a product involvement is considered unassessable.