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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1381

2. Registrant Information.

Registrant Reference Number: 1758599

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.

21-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: NEVADA

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. 1021-1177

Product Name: Pyrocide 300

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 9.57 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 6 %
    • PYRETHRINS
      • Guarantee/concentration 3 %

7. b) Type of formulation.

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.

Other

2. Demographic information of data subject

Sex: Male

Age: <=1 yr / < = 1 an

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Seizure

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?

Unknown

7. Exposure scenario

Non-occupational

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

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

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

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.)

1/21/2016 Caller states that her daughter's apartment was treated with the product sometime in the last two weeks of December 2015. All recommendations were followed to prepare the unit. The family left the unit, and the unit was ventilated and the carpets professionally cleaned prior to their return. On 1/1/2016, caller's (age) month old grandson developed myoclonic movement every 2 hours. The episodes were video taped and shown to his primary doctor, and he was referred for a neurological exam. The doctor admitted the child for an evaluation for neurotoxicity. He was given an electroencephalogram, electromyography, and other tests.

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 insidious development of the complications reported in this case is inconceivable and lacks biological plausibility. Secondly, the product use history is extremely vague and lacks any description of a known or defined point of direct exposure to this product. Even had casual or incidental contact with this product occurred, such illness would be unexpected and is not consistent with the toxicological profile of this product..