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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5675

2. Registrant Information.

Registrant Reference Number: 868114

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.

13-OCT-11

5. Location of incident.

Country: UNITED STATES

Prov / State: MARYLAND

6. Date incident was first observed.

22-SEP-11

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. 1021-1674-8845

Product Name: Hot Shot Bedbug + Flea Fogger

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .167 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .1 %
    • PYRETHRINS
      • Guarantee/concentration .05 %
    • PYRIPROXYFEN
      • Guarantee/concentration .1 %

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?

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: Female

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

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Coughing
    • Symptom - Respiratory irritation
    • Symptom - Sneezing

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

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)

None

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.

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.)

10/13/2011 This report is based on a vague history collected by a subregistrant of an MGK pesticide registered with the EPA. In the report the subject reports that a pesticide fogger had been used in a downstairs apartment at an unspecified period of time prior to her and her grandmother's development of illness. The only time frame mentioned in the subregistrant report was possibly 23 weeks prior to 10/13/2011. The subject reports developing sneezing and coughing on 10/6/2011. The subject also reports that her grandmother developed nausea and chest pain on 10/6/2011. The grandmother was described as experiencing a "heart attack". It is unclear if the grandmother was hospitalized but it was reported that she was receiving unspecified medications and she was under a doctor's care.

To be determined by Registrant

14. Severity classification.

Minor

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. Given that the product use history is extremely vague and appears to have been used in a separate residence of an apartment building, the possibility of significant exposure to the pesticide appears to be negligible. Furthermore, this pyrethroid based pesticide has no inherent cardiotoxicity and would not be directly responsible for chronic heart disease culminating in a "heart attack", which by definition typically means a myocardial infarction. The direct causal link between myocardial infarction that was somehow temporally associated with the use of this pyrethroid-based pesticide is biologically implausible.

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Cardiovascular System
    • Symptom - Chest pain
  • Gastrointestinal System
    • Symptom - Nausea
  • Cardiovascular System
    • Symptom - Other
    • Specify - Heart attack

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?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

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

Other

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.

Respiratory

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>3 days <=1 wk / >3 jours <=1 sem

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.)

10/13/2011 This report is based on a vague history collected by a subregistrant of an MGK pesticide registered with the EPA. In the report the subject reports that a pesticide fogger had been used in a downstairs apartment at an unspecified period of time prior to her and her grandmother's development of illness. The only time frame mentioned in the subregistrant report was possibly 23 weeks prior to 10/13/2011. The subject reports developing sneezing and coughing on 10/6/2011. The subject also reports that her grandmother developed nausea and chest pain on 10/6/2011. The grandmother was described as experiencing a "heart attack". It is unclear if the grandmother was hospitalized but it was reported that she was receiving unspecified medications and she was under a doctor's care.

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. Given that the product use history is extremely vague and appears to have been used in a separate residence of an apartment building, the possibility of significant exposure to the pesticide appears to be negligible. Furthermore, this pyrethroid based pesticide has no inherent cardiotoxicity and would not be directly responsible for chronic heart disease culminating in a "heart attack", which by definition typically means a myocardial infarction. The direct causal link between myocardial infarction that was somehow temporally associated with the use of this pyrethroid-based pesticide is biologically implausible.