Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0088

2. Registrant Information.

Registrant Reference Number: 1728655

Registrant Name (Full Legal Name no abbreviations): McLaughlin Gormley King Company

Address: 8810 Tenth Ave North

City: Minneapolis

Prov / State: MN

Country: USA

Postal Code: 55427-4319

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

Human

4. Date registrant was first informed of the incident.

29-NOV-15

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

18-OCT-15

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. 1021-1866-53853

Product Name: Black Flag Fogging Insecticide Formula 2

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration .15 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .15 %

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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: Male

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

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Chest pain

• Respiratory System
  • Symptom - Coughing
  • Symptom - Cyanosis
  • Symptom - Respiratory congestion
  • Symptom - Other
  • Specify - Low oxygen saturation
  • Symptom - Respiratory distress
  • Specify - Chronic obstructive pulmonary disorder
  • Symptom - Pneumonia

• Cardiovascular System
  • Symptom - Other
  • Specify - Congestive heart failure

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?

3

Week(s) / Semaine(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)

Unknown

10. Route(s) of exposure.

Respiratory

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.)

11/29/2015 Caller applied the product in his garage 1.5 months ago. Caller accidentally inhaled the product for several minutes in the course of this. Around 2 weeks later, caller developed a cough, congestion, and chest pain. He went to the emergency room, and was admitted to the hospital. His oxygen saturation was found to be very low, but caller does not recall the actual level. He was diagnosed with chronic obstructive pulmonary disorder, pneumonia, and congestive heart failure. He was treated with antibiotics and a bilevel positive air pressure machine. He was released after 3 weeks, and remains on oxygen. The symptoms did not resolve during the hospital stay. 12/4/2015 Attempted call back to the original caller. A message was left requesting follow up information. 12/7/2015 Call back to the original caller for follow up information. Caller was busy and would only say the he is improved.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. Any relationship between the use of this product and the delayed development of the complications reported in this case is inconceivable and lacks biological plausibility. The pathology behind Congestive heart failure takes several months to years to manifest and would not be something associated with the acute exposure to this particular pesticide 2 weeks prior to onset of signs and sympoms.