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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-0158
2. Registrant Information.
Registrant Reference Number: 3464251
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.
15-DEC-225. Location of incident.
Country: UNITED STATES
Prov / State: GEORGIA
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. Unknown
Product Name: Roundup Weed & Grass Killer RTU
- Active Ingredient(s)
- GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Round Up 365
- Active Ingredient(s)
- DIQUAT, PRESENT AS DIBROMIDE
- GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
7. b) Type of formulation.
Liquid
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.
Data Subject
2. Demographic information of data subject
Sex: Female
Age: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
- Cardiovascular System
- Symptom - Fainting
- General
- Symptom - Other
- Specify - Hypercapria Influenza A
- Respiratory System
- Symptom - Coughing
- Symptom - Cyanosis
- Symptom - Other
- Specify - Lung lining damage
- Symptom - Other
- Specify - Multifocal Pneumonitis
- Symptom - Other
- Specify - Hypersensitivity pneumonitis
- Symptom - Other
- Specify - Respiratory arrest
- Symptom - Shortness of breath
- Symptom - Wheezing
- Symptom - Heavy breathing
- Symptom - Respiratory failure
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)
Application
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
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.
Respiratory
11. What was the length of exposure?
Unknown / Inconnu
12. Time between exposure and onset of symptoms.
<=30 min / <=30 min
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.)
12/15/2022 Caller is calling to report hospitalization in relation to the RoundUp Weed Grass Killer Ready To Use, but cannot confirm thats what was used. She reports applying the product as directed about a year ago, around November 2021. 15 minutes after applying she began having a coughing and breathing heavily. She went to the emergency room and was given an oral steroid and nebulizer treatments. She has been to emergency room multiple times since. She went to her primary doctor around July 2022 and was diagnosed with Hypersensitivity Pneumonitis. He prescribed a steroid shot and albuterol inhaler. On November 26th, 2022 she was found passed out on the floor by her daughter and was hospitalized the same day. They ran intravenous antibiotics and she was diagnosed with acute respiratory failure. Her discharge paperwork says doctors were unsure if she was having effects related to hypoxia, hypercapnia, influenza, multifocal pneumonitis, or sepsis from an unspecified organism. She was discharged home on December 2nd, 2022 on continuous 3 liters oxygen, oxycodone, azithromycin, benzonatate, cefdinir, fluticasone, furosemide, and potassium and referred to a pulmonologist. She has not been able to find a pulmonologist who takes her insurance. She continues to use oxygen and is taking medication as prescribed. 12/19/2022 Callback from consumer. She reports the product name now as RoundUp 365, a new date of initial hospitalization of November 27th, 2022 instead of the 26th, new date of product use around December 2021. additional prescription of Xanax, albuterol treatments and an inhaler, and an additional diagnoses of Respiratory Failure, Hypercapria Influenza A , Multifocal Pneumonitis and was told the lining of her lungs were damaged by chemicals. echocardiogram, intravenous dye imaging, and unspecified bloodwork while in the hospital. Results of those exams are unknown.
To be determined by Registrant
14. Severity classification.
Major
15. Provide supplemental information here.
A temporal relationship exists between product use and the initial onset of symptoms but ongoing and worsening symptoms would not be expected when the product was used as directed with no known unintended exposure. Other differential diagnoses such as infectious diseases have not been ruled out and additionally been named as possible causes by her providers. Her symptoms have not resolved, and have worsened since initial exposure and no known additional exposure to the product has been reported.
