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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0690

2. Registrant Information.

Registrant Reference Number: ProPharma case: 1-42626834

Registrant Name (Full Legal Name no abbreviations): FMC Corporation

Address: 1735 Market Street

City: Philadelphia

Prov / State: Pennsylvania

Country: USA

Postal Code: 19103

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

Human

4. Date registrant was first informed of the incident.

04-DEC-15

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

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. 279-3388

Product Name: Purge III

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 3.05 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.95 %
    • PYRETHRINS
      • Guarantee/concentration .975 %

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: Pub. Area - Indoor/Zone publique - int

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?

Unknown

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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Cardiovascular System
    • Symptom - Tachycardia
    • Symptom - Chest pain
  • Respiratory System
    • Symptom - Other
    • Specify - collapsed lung, 25% lung capacity
  • Cardiovascular System
    • Symptom - Other
    • Specify - congestive heart failure
  • Respiratory System
    • Symptom - Other
    • Specify - sleep apnea
  • Liver
    • Symptom - Other
    • Specify - Liver damage

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?

5

Day(s) / Jour(s)

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.

Respiratory

11. What was the length of exposure?

>1 yr / > 1 an

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.)

1-42626834 - The reporter indicated that he had been exposed to an insecticidal spray containing the active ingredients pyrethrins, n-octyl bicycloheptene dicarboximide and pyrethrins. The reporter, a (age) year old, male, who had previously smoked for a period of 21 years stated that an insecticidal dispensing machine was installed 12 feet away from his desk at work and 7 feet from the floor either in December of 2013 or in January of 2014. Per the reporter, the machine fired a burst of product every 15-30 minutes and the burst was directed right towards his desk. Some unspecified time after the product was installed the reporter noted that his heart would race persistently. At times, it would race for up to 30 minutes after the activity that had initiated the fast heart rate had stopped. Then in February of 2014 the reporter noted a lot of chest pain and it became hard to breathe. The reporter was diagnosed with a collapsed lung, 25% lung capacity, low potassium and congestive heart failure. He was hospitalized for a period of 5 days and sent home on lisinopril, Klor-Con, furosemide, Carvedilol and aspirin. Over time, most of the medications were discontinued and now he is only taking the lisinopril, which the reporter states is meant to treat his liver damage. At some point, the reporter was also diagnosed with sleep apnea. On some unknown date, the machine was stopped for an unspecified period of time and the reporter indicated that his symptoms improved but in November 2015 it was started again and once again he started to feel chest pain and tightness. His symptoms improved after he was home for a period of about 3-4 hours but returned again when he went back to work. At the time of the call, the reporter indicated that the machine had been shut down once again and his symptoms had resolved. No additional information is available.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.