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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6570

2. Registrant Information.

Registrant Reference Number: 1-41804829

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

Address: Suite 200, 160 Quarry Park Blvd SE

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

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

Human

4. Date registrant was first informed of the incident.

21-OCT-15

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSISSIPPI

6. Date incident was first observed.

Unknown

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. Unknown

Product Name: Sevin (non-specific)

  • Active Ingredient(s)
    • CARBARYL
      • Unknown

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Res. - In Home / Rés. - à l'int. maison

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

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.

Data Subject

2. Demographic information of data subject

Sex: Male

Age: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

  • Blood
    • Symptom - Leukocytosis
  • General
    • Symptom - Cancer
    • Specify - Possible Leukemia
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Difficulty walking

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?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? Refer to field 13

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

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

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.)

9/4/2015 12:25:42 PM Sevin DustCaller states she has been staying somewhere for the last 3 weeks along with her (age) yo son. About 3 weeks ago her son became ill with weakness in his legs and he could not walk. They went to the pediatrician and the child was found to have a high WBC. The MD sent them home. The child's sxs became worse and he was checked into a hospital - they found his WBC was still climbing. Her son is getting weaker and weaker. He was admitted to (hospital name) on 9/1/15 and more tests were run. He was discharged and results are pending. The MDs are thinking the patient may have leukemia. Caller states that where she is staying has been using the product every night in the house for fleas. She knows they put it in the beds. Both she and her son have been exposed to the powder. The people using the product just found out last night that it should not be used inside the house. Caller states she told her son's MD about the product and the MD wants her to get as much information as possible about it.A: - Product is not designed to be used indoors- Persistent exposure could cause significant somes, some of which match the sxs your son is having.- Children may be more likely to develop CNS depression, seizures, and muscle weakness than SLUDGE signs. Other potential sxs could include drooling, twitches, low heart rate, severe sweating.- However, the product would not be expected to cause an elevated WBC, not would it be expected to cause cancer after 3 weeks- Rec. thorough decontamination of self and son for 15-20 min; be sure to wash all areas including genitals. - The home you are staying in should be decontaminated as well - rec. steam cleaning of all surfaces to avoid aerosolizing the product via vacuuming- Rec. you and your son not be in the home again until it is decontaminated- Rec. your MD perform a blood cholinesterase level test on your son to see how much of an influence (if any) the product may be having re: his sxs - gave case# and CB# 9/7/2015 1:01:35 PM PROSAR CB. Spoke with (name). Caller says that her son has been fine but will sometimes have weak spells. He is going to be rechecked by his doctor on 09/17/15. He is not currently on any medications.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.