Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2023

2. Registrant Information.

Registrant Reference Number: 2239494

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.

24-MAY-18

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

22-MAY-18

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 12455-143-3240

Product Name: Tomcat with Bromethalin Place Pacs

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

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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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: unknown amount placed around farm

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Difficulty swallowing
  • Symptom - Tongue swelling

• Skin
  • Symptom - Other
  • Specify - Angioedema

4. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

7. Exposure scenario

Unknown

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)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 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.)

5/24/2018 7:09:37 AM An individual reported that on May 22, 2018 he and his wife picked up all of the Tomcat with Bromethalin Place Pacs they had in various areas of their farm. Approximately 4 hours later his wife's tongue started swelling on the left side and she had difficulty swallowing and talking. She was evaluated at an emergency department where she was diagnosed with angioedema and received intravenous injections of diphenhydramine, methylprednisolone and famotidine, Her signs resolved within four hours of treatment. The patient's primary physician called on May 23, 2018 after reviewing the report from the emergency department and stated they didn't believe the patient's signs were a reaction to food since the swelling occurred on only one side of the tongue. The patient and caller were inquiring as to whether touching the product with bare hands and then touching one's mouth would cause this type of reaction though no specific exposure was described. During a follow-up call to the patient on May 29, 2018 she confirmed the above information and stated that no further signs had occurred.

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.