Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4973

2. Registrant Information.

Registrant Reference Number: 2283067

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

Address: 160 QUARRY PARK BLVD. SE Suite 200

City: Alberta

Prov / State: Calgary

Country: Canada

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

Human

4. Date registrant was first informed of the incident.

03-AUG-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

27-JUL-18

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. 72155-73

Product Name: 3-In-1 Insect, Disease, and Mite Control - Concentrate

• Active Ingredient(s)
  • FLUVALINATE-TAU
    • Guarantee/concentration .61 %
  • IMIDACLOPRID
    • Guarantee/concentration .47 %
  • TEBUCONAZOLE
    • Guarantee/concentration .65 %

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - Out Home / Rés - à l'ext.maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

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

Yes

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

• Gastrointestinal System
  • Symptom - Difficulty swallowing

• Nervous and Muscular Systems
  • Symptom - Muscle weakness
  • Symptom - Difficulty talking
  • Specify - Impaired Speech

• Eye
  • Symptom - Other
  • Specify - droopy eye

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

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

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.

Respiratory

11. What was the length of exposure?

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

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.)

8/3/2018 Caller reports that her husband applied the product outdoors on 7/27/2018. He attached the concentrated product to the hose and sprayed it up into trees. At some point later that day he began to experience problems with his speech and swallowing. He woke up the next morning and was severely impaired. Caller could barely understand him and he had difficulty swallowing. They went to their family doctor on 7/28/2018 and their doctor thought it was an allergic reaction. Husband was sent home with oral steroids. They arrived home and noticed that his right eye was drooping. Caller took him to the emergency room. His swallowing became more difficult, and he was admitted right away. They ran many tests (caller does not know all the tests or treatments done), though everything came back normal. Some lab work was sent to the (name) Clinic, and they are awaiting results. They are treating him for myasthenia gravis, and also spoke of an autoimmune disorder. They have given him intravenous fluids, pain medication, and anti-nausea medication. Originally they gave him antibiotics and steroids, but discontinued after testing. They say he may have a paralyzed nerve in his brain stem. 8/4/2018 Call from treating doctor regarding this case. The patient is currently on his service. the patient has been hospitalized for a week after developing neurological symptoms soon after applying the product. He has been scanned and has been ruled out for a cerebrovascular accident.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The effects reported cannot be correlated with the product reported. Inhalation of the mist / spray may result in minimal irritation to the mouth or throat or an upset stomach due to the poor taste of the product; however, the neurological effects noted are not part of the known toxicological profile for the product, as formulated, or the ingredients at such concentrations.