Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-4173

2. Registrant Information.

Registrant Reference Number: 1446880

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

Address: 295 Henderson Drive

City: Regina

Prov / State: SK

Country: Canada

Postal Code: S4N 6C2

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

Human

4. Date registrant was first informed of the incident.

19-AUG-14

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

6. Date incident was first observed.

26-JUL-14

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. 432-763

Product Name: Suspend SC

• Active Ingredient(s)
  • DELTAMETHRIN
    • Guarantee/concentration 4.75 %

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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 - Tongue swelling

• General
  • Symptom - Edema

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Muscle weakness
  • Symptom - Difficulty walking
  • Symptom - Other
  • Specify - Guillain Barr syndrome
  • Symptom - Numbness
  • Symptom - Paralysis

• Skin
  • Symptom - Tingling skin

• Gastrointestinal System
  • Symptom - Tingling in mouth

• Skin
  • Symptom - Paresthesia
  • Specify - tingling hands

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?

8

Day(s) / Jour(s)

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)

None

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

8/19/2014 Caller's brother sprayed this product on or about 7/26/2014 outside on the foundation of his home. He became ill the following day with some tingling in his mouth, nose, and hands. This lingered for a few days at which point he was seen a a local hospital. He was sent home without receiving any specific medical intervention. The effects he was experiencing worsened over the next several days and went back to the hospital. Caller believes he was seen by a second physician, and he was again discharged without any specific medical intervention. 8/20/2014 Call back to the original caller for follow up information. Brother was taken to another doctor, and found he had a virus. He is recovering. 9/5/2014 Call back to the original caller for more information regarding the events described. Brother was seen at the hospital twice, and was sent home with no intervention. Caller's brother hoped to get some fresh air and recover from this on a vacation, and drink lots of water in the process. About 6 days into the vacation he was finding it increasingly difficult to walk, and was seen at a local emergency room. The medical staff performed a computerized tomography scan and several focused ultrasounds. The cause of his symptoms was not determined. He was taken to another emergency room on 8/19/2014 or 8/20/2014, and at the time he was unable to walk on his own and he was experiencing facial muscle paralysis/drooping. Within several hours he was seen by several neurologists. He received a spinal tap and was diagnosed with Guillain Barr Syndrome, and was admitted to the hospital for treatment. They were told that this is not pesticide poisoning, and it is suspected that the trigger for the event was a recent tetanus vaccine that he had received. He was in the hospital for about 8 days. He received intravenous immunoglobulin therapy. He did not require a ventilator though as the ascending paralysis had not reached his ventilatory muscles. Upon discharge from the hospital, he was admitted to a rehabilitation facility to help him recover further. He was just discharged today from the rehabilitation facility. He is still using a walker or cane but is expected to recover fully with time.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.