Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0896

2. Registrant Information.

Registrant Reference Number: 1051080

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.

02-OCT-12

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

02-AUG-12

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. 432-763

Product Name: Suspend SC

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

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).

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.

Data Subject

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 - Shortness of breath
  • Cardiovascular System
    • Symptom - Hypotension
  • Respiratory System
    • Symptom - Difficulty Breathing
  • Blood
    • Symptom - Hypoxemia
    • Specify - Hypoxia

4. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

7

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

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.

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

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.)

Person reported on 02OCT2012 that her apartment was treated on 22JUNE2012 and again approximately 1 month later (end of JULY2012) by a pest control operator with this product. They returned again on or about 26SEPT2012 for a 3rd treatment. The caller was unable describe how she may have been exposed to this pesticide. On 10AUGUST (approximately 2 weeks following most recent application) she developed an episode of acute shortness of breath and had her friend drive her to see here usual physician. Due to the severity of her illness she was subsequently transported to a local ER for further evaluation and treatment. While in the ER she received O2 via a mask and (unknown) medications. She recalls at some time during this it was noted that her BP was 80/40mmHg, her O2 sat 87%, Co2 54. She was subsequently admitted to the hospital for on-going evaluation and care. She was discharged form the hospital 7 days later (17AUG2012) and is now on continuous O2 therapy to help manage her chronic breathing problems and had received a course of oral antibiotics as well. It is important to note that the patient already had a history of severe chronic obstructive pulmonary disease and hypertension prior to these pesticides being used in her home.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.