Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4153

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0033729

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.

11-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

08-JUN-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. 11556-128

Product Name: Advantage II Small Dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN

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7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

Units: mL

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).

A (age) year old, man, in unknown condition, with a concomitant medical condition of post traumatic stress disorder, was exposed to an unknown amount of Advantage II Small Dog (Imidacloprid-Pyriproxyfen) when he applied it to the 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: Male

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Dyspnea

• General
  • Symptom - Edema

• Cardiovascular System
  • Symptom - Hypertension

• Blood
  • Symptom - Hypercalcemia

• General
  • Symptom -
  • Specify - Type II Diabetes
  • Symptom - Swelling
  • Specify - legs and ankles

• Respiratory System
  • Symptom - Shortness of breath

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?

Yes

6. b) For how long?

5

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

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 01-Jun-2017, a (age) year old, man, in unknown condition, with a concomitant medical condition of post traumatic stress disorder, was exposed to an unknown amount of Advantage II Small Dog (Imidacloprid-Pyriproxyfen) when he applied it to the dog. No known direct exposure occurred. On approximately 08-Jun-2017, the individual experienced shortness of breath and swelling in the legs and ankles. He was examined by a physician, who determined that the individual was hyperglycemic, had type II diabetes and hypertension. It was unknown what diagnostics were performed. The individual was hospitalized, then started on a regimen of unspecified doses of furosemide, losartan, levofloxacin, hydralazine and carvedilol. On 13-Jun-2017, the individual was discharged from the hospital, but the clinical signs continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N - Unlikely. Unclear if direct or indirect product exposure occurred. Reported signs are not anticipated. Further no oral exposure to product reported. Other causes are more likely, indeed pateint was diagnosed with diabetes. Time to onset is exceptionally long. Overall, considering all aspects a product relation is deemed to be unlikely.