Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4003

2. Registrant Information.

Registrant Reference Number: 2015KP158

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

Address: 2920 Matheson Blvd. East

City: Mississauga

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.

20-JUL-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

03-APR-15

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. 11556-125

Product Name: Advantage II medium dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

---

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

On 03-Apr-2015, a (age) year old, woman, in poor condition, with ovarian cancer and an unknown venous problem, was exposed to an unknown amount of Advantage II Medium Dog (Imidacloprid-Pyriproxyfen) while applying it to her dog and some of the product came in contact with her hand.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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

• Respiratory System
  • Symptom - Irritated throat

• Blood
  • Symptom - Other
  • Specify - Lymphadenopathy

• Respiratory System
  • Symptom - Difficulty Breathing

• Gastrointestinal System
  • Symptom - Difficulty swallowing

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?

Unknown

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.)

Approximately one hour following the exposure, she developed throat irritation, swollen lymph glands, difficulty breathing, and difficulty swallowing. She presented to the Emergency Room for examination and treated with a numbing throat wash and discharged with no diagnosis. On 04Apr2015, she returned to the emergency room and was administered intravenous fluids, diphenhydramine (unknown dose), and a strep throat test which was negative.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Direct exposure to the hand occurred. No oral exposure reported. Reported signs throat irritation, swollen lymph glands, difficulty breathing, and difficulty swallowing are not expected after product application. The individual exposed in this case was in poor condition, with ovarian cancer and an unknown venous problem, which may have contributed the signs. Other infectious causes are more likely. Time to onset is short though. Finally, a product relation considered as unlikely.