Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3621

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0039359 (Report 505499)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

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

Human

4. Date registrant was first informed of the incident.

17-JUL-18

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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 Large Dog

• 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 an unspecified date in Sep 2017, a woman, in unknown condition, with no known concomitant medical conditions, was exposed to multiple Seresto Large Dog (Flumethrin-Imidacloprid) collars after the collars were applied to her dogs.

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: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Tingling skin

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Unknown

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

Contact with treated area

What was the activity? The person was exposed to the collars after the collars were applied to her dogs.

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.

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 an unspecified date in approximately Sep 2017, the woman experienced tingling in her fingers and hands. On unspecified dates in approximately 2018, the owner left home for multiple days and the tingling resolved. When the owner returned home and she interacted with the dogs, the symptom recurred and worsened when she pet her dogs. No known medical intervention was sought.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

O - Unclassifiable/unassessable Direct product exposure occurred when the individual applied the collars to her animals. Affected site is compatible with exposed site. Reported tingling sensation is consistent with dermal exposure to collar. Later on sign reoccurred after short time with indirect product exposure. Time to onset is unknown for initially reported sign with respect to direct exposure. Hence other causes must be considered. Overall, a product involvement is unassessable.