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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1378

2. Registrant Information.

Registrant Reference Number: 1735307

Registrant Name (Full Legal Name no abbreviations): Bell Laboratories, Inc.

Address: 3699 Kinsman Blvd

City: Madison

Prov / State: WI

Country: USA

Postal Code: 53704

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

Human

4. Date registrant was first informed of the incident.

10-DEC-15

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

08-DEC-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Contrac (non-specific)

  • Active Ingredient(s)
    • BROMADIOLONE

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?

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: Female

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

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Nausea
  • Nervous and Muscular Systems
    • Symptom - Headache
    • Symptom - Muscle cramps
  • Skin
    • Symptom - Paresthesia
    • Specify - Tingling in hands

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

No

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?

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

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.)

12/10/2015 The caller states that the her apartment management put the products in the floor joists of her apartment 3-4 weeks prior to the call. Approximately 24-36 hours prior to the call she began to experience symptoms of muscle cramps, headache, nausea, and tinging in the hands. The symptoms wax and wane but seem to begin about 30 minutes after being in her home but she could not determine how long it took for her symptoms to resolve once she left the home. Her husband also is experiencing symptoms of muscle cramps, tingling in the hands and dizziness although she does not know when his symptoms started or if they correlate to being in the home. The caller denies any direct exposure to the product but is concerned she may be inhaling it. The caller was advised that the product dose not release pesticide into the air and that the reported symptoms do not correlate with exposure. Advised her and her husband to consult their physician.

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.

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

  • Nervous and Muscular Systems
    • Symptom - Dizziness
  • Skin
    • Symptom - Paresthesia
    • Specify - Tingling in the hands
  • Nervous and Muscular Systems
    • Symptom - Muscle cramps

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

No

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?

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

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.)

12/10/2015 The caller states that the her apartment management put the products in the floor joists of her apartment 3-4 weeks prior to the call. Approximately 24-36 hours prior to the call she began to experience symptoms of muscle cramps, headache, nausea, and tinging in the hands. The symptoms wax and wane but seem to begin about 30 minutes after being in her home but she could not determine how long it took for her symptoms to resolve once she left the home. Her husband also is experiencing symptoms of muscle cramps, tingling in the hands and dizziness although she does not know when his symptoms started or if they correlate to being in the home. The caller denies any direct exposure to the product but is concerned she may be inhaling it. The caller was advised that the product dose not release pesticide into the air and that the reported symptoms do not correlate with exposure. Advised her and her husband to consult their physician.

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.