Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4956

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0047501

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

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Human

4. Date registrant was first informed of the incident.

27-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

27-MAY-17

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
  • 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 April 27, a (age) year old woman, with concomitant condition of respiratory syncitial virus, and treated with oral prednisone and oral clavulanic acid/amoxicillin, was exposed to an unknown amout of Seresto collar large dog when the collar was applied to her dog by her boyfriend. on May 17, the woman experienced ocular pain, ocular redness, blurred vision and eyelid edema; she was examined by a physician who diagnosed eye infection

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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Pain
  • Symptom - Red eye
  • Symptom - Blurred vision
  • Specify - Vision blurred
  • Symptom - Edema
  • Symptom - Other
  • Specify - Eye disorder NOS

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)

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

12. Time between exposure and onset of symptoms.

>3 days <=1 wk / >3 jours <=1 sem

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 27 May 2017, the individual experienced ocular pain, ocular redness, blurred vision and eyelid edema. She was examined by an ocular physician who determined there was an eye infection, but no known treatments were provided and the clinical signs continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N-Unlikely: Product exposure reported however unknown if direct or indirect. No ocular exposure reported. The collar is odorless and its active ingredients not volatile at room temperature. Eye disorders or related signs are not expected. Time to onset of one month is long. Other causes are more likely, physician determined there was an eye infection. Overall product involvement is considered unlikely.