Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5904

2. Registrant Information.

Registrant Reference Number: 2806767

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.

08-NOV-20

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

08-NOV-20

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: Bromethalin (non-specific)

• Active Ingredient(s)
  • BROMETHALIN
    • Unknown

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7. b) Type of formulation.

Bait

Application Information

8. Product was applied?

Unknown

9. Application Rate.

Unknown

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).

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.

Medical Professional

2. Demographic information of data subject

Sex: Male

Age: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Fever
  • Symptom - Lethargy

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?

12

Hour(s) / Heure(s)

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

Poisoning from ingestion of the pesticide

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.

Oral

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 h

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.)

11/8/2020 Caller is a physician treating a 5 year old patient that ingested 1/3 of a block of the product around 5 hours ago. After ingestion the patient was lethargic and had a fever. He was taken to the emergency department, and had a temperature of 103.6 degrees Fahrenheit. He was given acetaminophen and the fever decreased to 100.8 degrees Fahrenheit. Neurological examination was okay, and he was active and alert. They planned to admit the child for further monitoring. 11/9/2020 Call back to the treating facility for follow up. The child was discharged today after 12 hours of observation. He developed no further symptoms, and no further lab tests were drawn. No further informaiton was received.

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.