Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2021-6056

2. Registrant Information.

Registrant Reference Number: USA-ZZELANCO-US2021_027738

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.

Human

4. Date registrant was first informed of the incident.

27-SEP-21

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

01-JUL-21

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 Large Dog Collar

• 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.

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).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Other
  • Specify - Heart insufficiency

• Nervous and Muscular Systems
  • Symptom - Headache

• Gastrointestinal System
  • Symptom - Weight loss
  • Symptom - Vomiting

• General
  • Symptom - Swelling
  • Symptom - Hypothermia

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Renal System
  • Symptom - Blood in urine

• Nervous and Muscular Systems
  • Symptom - Muscle tremors
  • Symptom - Anxiety

• Cardiovascular System
  • Symptom - Bradycardia

• Gastrointestinal System
  • Symptom - Bloody diarrhea

• Eye
  • Symptom - Other
  • Specify - Impaired vision

• Gastrointestinal System
  • Symptom - Stomach pain

• General
  • Symptom - Other
  • Specify - Swollen lymph nodes

• Respiratory System
  • Symptom - Irritated throat

• Skin
  • Symptom - Brittle nails, white striations
  • Specify - Fingernails would fall off

• Cardiovascular System
  • Symptom - Other
  • Specify - Heart stopping

• Eye
  • Symptom - Other
  • Specify - Couldnt see

• Nervous and Muscular Systems
  • Symptom - Difficulty walking

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

On 27-Sep-2021, Elanco was contacted by a human patient who reported exposure to a Seresto Large Dog collar when she applied the product to her dog on 06Apr2021. On approximately 1st May 2021, the individual experienced her heart stopping and she went to the hospital. It was unknown if treatments were performed or if her symptoms continued. Elanco considers this case closed; additional information will be filed as received.Update. Follow up received on 14 Oct 2021.Caller reported using this product on her dog for the first time in July 2021 (Treatment start date has been changed to 1 Jul 2021)On unspecific date in July 2021 (estimated as 1 Jul 2021 for reporting purpose) caller reported she started to experience events of unable to walk, increased anxiety, tremors, couldnt stay warm, couldnt see, leg swelling where she couldnt walk for 3 months (had to use a walker), abdominal pain with eating or drinking, vomiting, massive headaches, fingernails would fall off (very brittle), and she would experience blood in her urine and feces. On unspecific date in July 2021 (estimated as 1 Jul 2021 for reporting purpose). Caller reports she went to the emergency clinic in July 2021 where she stayed for about 2 hours. An electrocardiogram, blood work, and a CAT scan were done and results were unknown. Caller states her heart rate dropped to 30 beats per minute and the clinic wanted to life flight her to another hospital but she refused and discharged herself. Caller reported her signs continued and she went from weighing 143 pounds down to 95 pounds. On an unknown date in September 2021 (estimated as 1 Sep 2021 for reporting purpose), caller stated she had another emergency clinic visit in where she was tested negative for West Nile, AIDS, and Hepatitis. Caller stated she was discharged from the clinic after 1 hour and was given crutches because she was having trouble walking. Caller stated the clinic suggested she may have torn a ligament (not coded because not confirmed).Caller reported she would handle her dogs collar daily to make sure it was adjusted correctly.Caller reported when she finally removed her dogs collar her symptoms started to improve within 2 days but are not completely resolved. Caller stated she had a consult with a Neurologist on 4 Oct 2021 but by then she had already removed the collar and her signs were improving. Caller stated she made sure to mention this to the Neurologist. Caller stated no additional treatments were done.Follow up received on 23Oct2021: Caller states she was previously wheelchair-bound but is now walking better. The rest of her symptoms have resolved.She still has swollen lymph nodes and her throat is irritated (estimated as 23 Oct 2021* for reporting purpose). Elanco consider this case closed.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.