Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5765

2. Registrant Information.

Registrant Reference Number: 3702737

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: 160 Quarry Park Boulevard SE Suite 130

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

29-AUG-23

5. Location of incident.

Country: UNITED STATES

Prov / State: CONNECTICUT

6. Date incident was first observed.

24-AUG-23

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. 71995-49

Product Name: ROUNDUP CONCENTRATE MAX CONTROL 365

• Active Ingredient(s)
  • DIQUAT
    • Unknown
  • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
    • Unknown

---

7. b) Type of formulation.

Liquid

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.

Medical Professional

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Acute respiratory distress syndrome

• General
  • Symptom - Other
  • Specify - Multi organ failure

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - No neurological activity

• Renal System
  • Symptom - Renal failure

• Gastrointestinal System
  • Symptom - Other
  • Specify - Esophageal burning
  • Symptom - Nausea
  • Symptom - Vomiting

• Respiratory System
  • Symptom - Decreased pulmonary function

• General
  • Symptom - Other
  • Specify - Organ toxicity

• Respiratory System
  • Symptom - Other
  • Specify - Lungs a complete whiteout on chest x-ray

• Renal System
  • Symptom - Anuria

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - No cough reflex
  • Symptom - Other
  • Specify - No gag reflex
  • Symptom - Other
  • Specify - No pain response

• Eye
  • Symptom - Decreased pupillary light reflex

• Renal System
  • Symptom - Creatinine increased

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

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.

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.)

8/29/2023 The caller is inquiring about where to have the patient's levels checked, if there is one, for Glyphosate and Diquat. Caller reports the following: He is a pharmacist at toxicology department at the hospital, on the team treating the patient. On 24Aug2023 at 7am local time, the patient intentionally ingested 16oz of the product with also having Melatonin and Valproic acid in his system. The patient was initially seen in another hospital before being transferred to the current hospital. Little information about the symptoms that the patient experienced but the patient is on multiple life support measures including extracorporeal membrane oxygenation and continuous veno-venous hemofiltration and sedation for a day and is showing no signs of neurological activity, multi organ failure including profound renal failure and acute respiratory distresses syndrome leading to lung functions going down. They did not get exact product information until last night, 28Aug2023 which confirmed that Diquat is in the product consumed. 8/31/2023 Callback attempted to the initial caller. Left message on voice mail with case number and callback information. 9/1/2023 Listened to the original call recording. Caller also reported the following: Valproic Acid, level known but not provided, and Melatonin were also reported as ingestants. RoundUp was the "primary ingestion." They initially thought it was just glyphosate in the product but when the patient developed renal failure, acute respiratory distress syndrome and decreased lung function they suspected diquat. They were able to confirm the product the previous night before the call and confirmed both glyphosate and diquat were in the product. They did not specify reason for wanting the levels. 9/1/2023 Callback to hospital pharmacist to follow up on patient status.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Incident narrative, continued: . He reports the following: The patient initially drove himself and presented ambulatory, alert and oriented to a smaller hospital ER sometime on August 24, 2023 with complaints of esophageal burning, nausea and vomiting. Patient said he drank a RoundUp product in addition to Valproic Acid and Melatonin over the prescribed amount, but the pharmacist does not recall any specific amounts being reported. He was transferred to their larger hospital August 25th or early am August 26, 2023 with the first ICU notes dated early am August 26, 2023. They were told by the smaller hospital that the product ingested was RoundUp, and they were initially only considering it to be a glyphosate exposure and treating supportively. However, with the way the patient's condition rapidly declined they began to suspect an exposure to Diquat, and this is when they started looking for ways to do serum testing to confirm what the ingestion was and determine if it was a diquat and glyphosate exposure. They understood this would not change the course of symptomatic and supportive care, but the reasoning to pursue levels was more from an academic interest standpoint as a possible case report as this type of ingestion is so rare in their experience. The patient's Valproic Acid levels peaked at 200 after approximately 2 days, and then gradually decreased to therapeutic levels. They generally do not get concerned about Valproic Acid levels until they reach 500. They did not test for Melatonin since in their experience, even large ingestions have not been cause for toxicity concern or require treatment. Over the first 24-48 hours after admission to their hospital, the patient remained alert and oriented though his creatinine levels were increasing and kidney function was declining, then he rapidly declined with signs of organ toxicity (no specific lab test results known). The initial chest xray done August 25, 2023 looked normal, but 2 days later on repeat chest xray, the caller states the pulmonologist verbally referred to the patient's lungs: "are a complete whiteout". with the Xray image of the lung fields a white color where you would usually see black. They were later informed by the initial hospital that the product was confirmed as they had the empty bottle of ROUNDUP CONCENTRATE MAX CONTROL 365 identified by the EPA number which was found in the patient's car that he drove to the ER in and stated that the pt poured 16 oz of this undiluted product into a type of drinking bottle and drank it. (ER also has that bottle). Patient's status is known up to yesterday to the pharmacist. Patient has had no urine output for the last 5 days as of yesterday. He remains on life support with minimal neurological response for the past few days, and no cough or gag reflex. There had also been no pain response and his pupils had been unresponsive to light. In a chart note update yesterday it was noted that the patient's pupils showed some response to light, and he appeared to withdraw to pain. Their hospital team contacted NMS Labs to pursue serum testing since the initial hospital drew lab work within 2 hours of the ingestion and these samples are still available for testing. They were informed by the lab that the samples needed to have been stored in an opaque container away from light to be tested. The samples available were not collected or stored in opaque containers and have been stored in the fridge. The pharmacist would still be interested in pursuing serum testing if there are any other known resources or options to utilize the samples they do have from an academic interest standpoint. 9/7/2023 Follow up call to hospital pharmacist attempted. Left message on voicemail requesting return call with case number and callback number. 9/12/2023 Follow up call to hospital pharmacist attempted. Left message on voicemail requesting return call with case number and callback number.