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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6632

2. Registrant Information.

Registrant Reference Number: 2309573

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

Domestic Animal

4. Date registrant was first informed of the incident.

18-SEP-18

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

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. 12455-95

Product Name: Fastrac All-Weather Blox

  • Active Ingredient(s)
    • BROMETHALIN
      • Guarantee/concentration .01 %

7. b) Type of formulation.

Bait

Application Information

8. Product was applied?

No

9. Application Rate.

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

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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: Male

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

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Abdominal distension
    • Symptom - Bloating
    • Symptom - Constipation
    • Symptom - Other
    • Specify - Colon pain
    • Symptom - Other
    • Specify - Weight gain
  • Blood
    • Symptom - Leukocytosis
    • Symptom - Hyperglycemia
    • Symptom - Other
    • Specify - Eosinophilia
    • Symptom - Other
    • Specify - Monocytosis
    • Symptom - Other
    • Specify - Hemoglobin A1C increased
  • Gastrointestinal System
    • Symptom - Stomach pain

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?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

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

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

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.)

9/18/2018 12:00:10 PM The reporter purchased two packages of product approximately one year ago. He has been handling the containers with his hands though had no direct contact with the product that he is aware of. He was trying to determine the cause of his own symptoms and those experienced by his mother as their doctors have not been able to. He had brought a container of product to his mother's house and he believes she used some of the packs, though no specific exposure to the product is known. He also mentioned that his mother's two dogs died one week apart within the past eight weeks. Both dogs died at home in the back yard. No diagnostics were performed on them in order to determine a cause of death. The reporter did not have any other information about the dogs and declined discussing them further. The reporter has been experiencing colon pain, constipation, bloating, abdominal pain, and weight gain all of which have worsened over the past 18 months. He was evaluated by a doctor several times and diagnostics including a CT scan and a colonoscopy, both of with unremarkable results. Blood tests showed elevated A1C (6.4 with normal less than 5.7, mild eosinophilia (738 with normal up to 500), mild monocytosis (1202 with normal up to 950), mild leukocytosis (11.9 with normal up to 10.8), and mild hyperglycemia (114 with high normal 99). He was also evaluated by an oncologist who stated that his signs were due to smoking and his blood being too thick. The reporter's mother was previously hospitalized for two weeks (dates unknown) with symptoms including hallucinations, shaking as if she was having a seizure, and she also had a stroke. She was admitted again two weeks prior and still hospitalized at the time of the call. Her symptoms included abdominal pain and distention, vomiting, constipation, and a low-grade fever. She was treated with IV fluids, antibiotics, heparin, and had two blood transfusions. Diagnostics included a CT scan, endoscopy, and colonoscopy but the doctors have not provided a diagnosis. A bone marrow test was also performed but results were not available at the time. During a follow-up call on 9/28/2018 the reporter stated his mother was discharged from the hospital that day. The doctors did not have an opinion as to whether the product was a cause of her symptoms.

To be determined by Registrant

14. Severity classification.

Moderate

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: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Abdominal distension
    • Symptom - Constipation
    • Symptom - Stomach pain
    • Symptom - Vomiting
  • General
    • Symptom - Fever
  • Nervous and Muscular Systems
    • Symptom - Hallucination
    • Specify - Hallucinations/Delusion
    • Symptom - Shaking
  • Cardiovascular System
    • Symptom - Stroke

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)

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

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.)

9/18/2018 12:00:10 PM The reporter purchased two packages of product approximately one year ago. He has been handling the containers with his hands though had no direct contact with the product that he is aware of. He was trying to determine the cause of his own symptoms and those experienced by his mother as their doctors have not been able to. He had brought a container of product to his mother's house and he believes she used some of the packs, though no specific exposure to the product is known. He also mentioned that his mother's two dogs died one week apart within the past eight weeks. Both dogs died at home in the back yard. No diagnostics were performed on them in order to determine a cause of death. The reporter did not have any other information about the dogs and declined discussing them further. The reporter has been experiencing colon pain, constipation, bloating, abdominal pain, and weight gain all of which have worsened over the past 18 months. He was evaluated by a doctor several times and diagnostics including a CT scan and a colonoscopy, both of with unremarkable results. Blood tests showed elevated A1C (6.4 with normal less than 5.7, mild eosinophilia (738 with normal up to 500), mild monocytosis (1202 with normal up to 950), mild leukocytosis (11.9 with normal up to 10.8), and mild hyperglycemia (114 with high normal 99). He was also evaluated by an oncologist who stated that his signs were due to smoking and his blood being too thick. The reporter's mother was previously hospitalized for two weeks (dates unknown) with symptoms including hallucinations, shaking as if she was having a seizure, and she also had a stroke. She was admitted again two weeks prior and still hospitalized at the time of the call. Her symptoms included abdominal pain and distention, vomiting, constipation, and a low-grade fever. She was treated with IV fluids, antibiotics, heparin, and had two blood transfusions. Diagnostics included a CT scan, endoscopy, and colonoscopy but the doctors have not provided a diagnosis. A bone marrow test was also performed but results were not available at the time. During a follow-up call on 9/28/2018 the reporter stated his mother was discharged from the hospital that day. The doctors did not have an opinion as to whether the product was a cause of her symptoms.

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 III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Unknown exposure to pesticide

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

9/18/2018 12:00:10 PM The reporter purchased two packages of product approximately one year ago. He has been handling the containers with his hands though had no direct contact with the product that he is aware of. He was trying to determine the cause of his own symptoms and those experienced by his mother as their doctors have not been able to. He had brought a container of product to his mother's house and he believes she used some of the packs, though no specific exposure to the product is known. He also mentioned that his mother's two dogs died one week apart within the past eight weeks. Both dogs died at home in the back yard. No diagnostics were performed on them in order to determine a cause of death. The reporter did not have any other information about the dogs and declined discussing them further. The reporter has been experiencing colon pain, constipation, bloating, abdominal pain, and weight gain all of which have worsened over the past 18 months. He was evaluated by a doctor several times and diagnostics including a CT scan and a colonoscopy, both of with unremarkable results. Blood tests showed elevated A1C (6.4 with normal less than 5.7, mild eosinophilia (738 with normal up to 500), mild monocytosis (1202 with normal up to 950), mild leukocytosis (11.9 with normal up to 10.8), and mild hyperglycemia (114 with high normal 99). He was also evaluated by an oncologist who stated that his signs were due to smoking and his blood being too thick. The reporter's mother was previously hospitalized for two weeks (dates unknown) with symptoms including hallucinations, shaking as if she was having a seizure, and she also had a stroke. She was admitted again two weeks prior and still hospitalized at the time of the call. Her symptoms included abdominal pain and distention, vomiting, constipation, and a low-grade fever. She was treated with IV fluids, antibiotics, heparin, and had two blood transfusions. Diagnostics included a CT scan, endoscopy, and colonoscopy but the doctors have not provided a diagnosis. A bone marrow test was also performed but results were not available at the time. During a follow-up call on 9/28/2018 the reporter stated his mother was discharged from the hospital that day. The doctors did not have an opinion as to whether the product was a cause of her symptoms.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. 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.