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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-0595

2. Registrant Information.

Registrant Reference Number: 2601028

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.

26-JAN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

26-JAN-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. 12455-120-3240

Product Name: Tomcat Mouse Killer I

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

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: Res. - Out Home / Rés - à l'ext.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.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Eye
    • Symptom - Pupil dilation
  • Gastrointestinal System
    • Symptom - Nausea
    • Symptom - Salivating excessively
    • Symptom - Vomiting
  • General
    • Symptom - Fever
  • Liver
    • Symptom - Elevated liver enzymes
    • Specify - Elevated AST
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Specify - Lower extremity weakness
  • General
    • Symptom - Laryngitis
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors

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?

5

Day(s) / Jour(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?

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.)

1/26/2020 Caller is an emergency medical technician treating a x year old child who was found with the product about 3 hours ago. The product was spread across the ground, but no one saw the child ingest it. The parents contacted 911 because the child developed nausea, vomiting, salivation, and dilated pupils. The child was en route to the hospital via ambulance. 1/27/2020 Call to the child's mother for follow up. The child was intubated at the hospital and tests are pending. The phone connection was poor and the call disconnected. Call to the treating facility and spoke to a nurse. The child was transferred from another facility. At the initial facility the child was very lethargic so she was intubated for airway protection. An older sibling witnessed the child ingesting a significant portion of the product. She has no known underlying health conditions. She is currently sedated and on a ventilator. She was given Rocuronium and sedation. She is moving around a bit, but not purposeful movements. She does have cough and gag reflex. Pupils are equal, reactive but sluggish, and 1 to 2 millimeters. She did have a temperature of 104.3 degrees Fahrenheit, so they put her on the arctic sun protocol to cool her down. Her temperature is now 97.8 degrees Fahrenheit. She has a nasogastric tube and is getting charcoal every 4 hours. Results of a urinalysis and Procalcitonin test were pending. No testing for brain swelling had been performed as no signs of brain welling were noted. 1/28/2020 Attempted call back to the treating facility. A message was left requesting follow up information. 1/29/2020 Call back to the treating facility for follow up. Spoke with a nurse. They performed magnetic resonance imaging last night, and had to repeat it today because they missed a certain area. The result from last night was normal, and the results from today are pending. The child is awake and alert, and is reaching for toys. They are about to extubate her. They had her on vancomycin. Her blood culture was negative and urine was pending. They are planning to stop the vancomycin today. There was no official sepsis work up. Call back to the treating facility and spoke to the nurse. The magnetic resonance imaging was unremarkable. Blood culture and urine were negative. She was extubated earlier today and is currently on room air. Temperature today has been 99 to 100 degrees Fahrenheit. She tracks, gestures, reaches for toys, and was speaking and crying after extubation. She has not been talking much as her throat may be sore after extubation. They ran a respiratory culture due to vomiting during extubation, results are pending. Her urine toxicology screen was positive for benzodiazepine. The nurse was unsure of the timing of the test, and stated she was given Versed for intubation and has been on a Versed drip. She should stay in the intensive care unit tonight with plans to move her out tomorrow. They are still thinking product is the cause. 1/30/2020 Call back to the treating facility for follow up. The patient was moved out of the intensive care unit. No fever today. She has been talking a bit more, but is still whispering. The tracheal culture preliminary gram stain results came back negative, and the culture is pending. She was started on Acetylcysteine on 1/28/2020 due to elevated liver function tests. On 1/29/2020 her aspartate aminotransferase was 103 and is 59 today. Alanine aminotransferase remained normal. Acetylcysteine will be discontinued tomorrow. She had some lower extremity weakness this morning, but later got out of bed by herself and pulled her nasogastric tube out. She is on a thick liquid diet and has a swallow test tomorrow. She is starting to eat more, responds to commands, responds with yes and no and knows everyone. Intermittent tremors were reported. 1/31/2019 The child's labs and vitals were normal and she was discharged. A follow up call was placed to the child's mother who disconnected without providing further information.

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.