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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2136

2. Registrant Information.

Registrant Reference Number: 2424627

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.

17-APR-19

5. Location of incident.

Country: UNITED STATES

Prov / State: ARIZONA

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. 12455-83-3240

Product Name: Tomcat Rat & Mouse Bait Place Pac (discontinued)

  • Active Ingredient(s)
    • DIPHACINONE (PRESENT IN FREE FORM OR AS SODIUM SALT)
      • Guarantee/concentration .005 %

7. b) Type of formulation.

Bait

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Other / Autre

Préciser le type: Glued inside hood of a car

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.

Other

2. Demographic information of data subject

Sex: Female

Age: <=1 yr / < = 1 an

3. List all symptoms, using the selections below.

System

  • Blood
    • Symptom - Other
    • Specify - Coombs positive
    • Symptom - Anemia
  • General
    • Symptom - Jaundice

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?

>6 mos <=1 yr / > 6 mois < = 1 an

12. Time between exposure and onset of symptoms.

>6 mos / > 6 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.)

4/17/2019 Caller has worked for a company that provides vehicles for the past 5 years. Caller reports driving a company vehicle before and during her entire pregnancy. She was in the car for about 6 hours per day. She detected a bad odor in the car which would give her a headache. She found packages of the product glued inside the hood of the car. She requested two other vehicles, and found product in the engines in the other two vehicles as well. She had a normal pregnancy, and delivered her baby on 1/22/2019. At birth, her daughter was anemic, had jaundice, and was Coombs positive. Caller states that her and her daughter's blood was not compatible. No further information was received in this case.

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.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Headache

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

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.

Respiratory

11. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 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.)

4/17/2019 Caller has worked for a company that provides vehicles for the past 5 years. Caller reports driving a company vehicle before and during her entire pregnancy. She was in the car for about 6 hours per day. She detected a bad odor in the car which would give her a headache. She found packages of the product glued to the hood of the car. She requested two other vehicles, and found product in the engines in the other two vehicles as well. She had a normal pregnancy, and delivered her baby on 1/22/2019. At birth, her daughter was anemic, had jaundice, and was Coombs positive. Caller states that her and her daughter's blood was not compatible. No further information was received in this case.

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.