Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0147

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0059951 (Report 678180)

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G4T2

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

Human

4. Date registrant was first informed of the incident.

23-NOV-20

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

01-SEP-19

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 unknown

• 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?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

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.

Other

2. Demographic information of data subject

Sex: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Specify - convulsions
  • Symptom - Shaking
  • Specify - jerking, shaking

• General
  • Symptom - Anaphylaxis

4. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

11

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

Application

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.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 h

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 approximately 01-Sep-2019, a man, with no known concomitant medical conditions, was exposed to a Seresto Small Dog (Flumethrin-Imidacloprid) collar when he placed the collar around the neck of a dog in the home. Approximately 2 hours post exposure, the man experienced anaphylaxis, shaking, and convulsions. The man was evaluated by a physician in the emergency room, administered an unspecified medication, and placed in a coma. On approximately 08-Sep-2019, the man recovered. On approximately 14-Sep-2019, the man was exposed to a Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar when he placed the collar around the neck of another dog in the home. Approximately 2 hours post exposure, the man experienced anaphylaxis, jerking, shaking, and convulsions. The man was evaluated by a physician in the emergency room, administered an unspecified medication, and placed in a coma. On approximately 18-Sep-2019, the man recovered.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

B - Possible Individual was exposed to unknown amount of collar while applying the collar. Affected site is not in line with exposed site. No information about indirect exposure of affected site via contaminated hands. Reported serious sign such as convulsion is not expected with appropriate product use as not consistent with product¿¿¿¿¿¿s pharmacological profile. Shaking is not expected sign and, in this case likely associated with convulsion. Hypersensitivity reactions such as anaphylaxis to the collar are not typically seen and not consistent with product¿¿¿¿¿¿s pharmacological profile as well. None of the active ingredients is known to have immuno-toxicological effects nor causing dermal sensitization. However, hypersensitivity may exceptionally occur with direct product exposure to every product combined with respective disposition in the individual. Signs resolved and then reoccurred after subsequent exposure to collar. Product information states that user should wash their hands with cold water after fitting of collar. It is unknown whether this was followed or not. Time to onset is short. Considering short time to onset and reappear of reactions after product exposure, product involvement cannot be ruled out. Thus, product involvement is assessed as possible.