Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1235

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0004022 (Report 470043)

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.

07-FEB-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

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 approximately May 2017, a woman, in unknown condition, with no known concomitant medical conditions, was exposed to an unknown amount of 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar when she placed it on her dog.

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

• General
  • Symptom - Other
  • Specify - Allergy

• Eye
  • Symptom - Other
  • Specify - Unspecified eye disorder.

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

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.

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

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 May 2017, the individual exhibited an unspecified eye disorder. On unspecified dates in approximately 2017, the individual was examined by 5 different physicians and an allergy specialist. It was determined the individual had an allergy. No known treatments were provided and the clinical signs continued. On an unspecified date in approximately Dec 2017, the individual removed the collar from the dog. The clinical signs continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

O-Unassessable: No eye exposure reported. The collar is odorless and its active ingredients are not volatile at room temperature. Eye disorders or related signs are not expected, in this case likely associated with other reported signs (e.g. allergy NOS). Moreover, reported allergy is not expected, especially that neither direct nor indirect product exposure described and no information about affected site. A lot of information missing (e.g. time to onset, adverse event details, duration, outcome). Product involvement is considered unassessable. Initial assessment confirmed by medical doctor.