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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-3408
2. Registrant Information.
Registrant Reference Number: 640951
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: #200, 160 Quarry Park Blvd SE
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.
02-JUN-105. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
6. Date incident was first observed.
31-MAY-10Product 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: Tempo (Bayer CropScience)
- Active Ingredient(s)
- CYFLUTHRIN
- Unknown
- CYFLUTHRIN
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Triumph Insecticide (Syngenta)
- Active Ingredient(s)
- ISAZOFOS
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: Female
Age: >1 <=6 yrs / > 1 < = 6 ans
3. List all symptoms, using the selections below.
System
- Eye
- Symptom - Tearing
- Gastrointestinal System
- Symptom - Salivating excessively
- Symptom - Vomiting
- Nervous and Muscular Systems
- Symptom - Unconsciousness
- Respiratory System
- Symptom - Respiratory distress
- Symptom - Pulmonary edema
- Symptom - Abnormal lung sounds
- Symptom - Shortness of breath
- Symptom - Other
- Specify - Damaged vocal chords
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)
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 / <=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.)
6/2/2010 Caller is a poison information specialist calling from a poison control center regarding a two year old child that drank a liquid thinking it was lemonade on 5/29/2010. This liquid had been inappropriately stored in a plastic squeeze water bottle. Apparently, a neighbor of the patient's parents have given the parents the plastic bottle containing one or two kinds of insecticides. Despite several follow-up calls with the treating hospital and a local public poison center in (State), no one has been able to confirm the contents of this bottle, although Tempo insecticide containing the pyrethroid cyfluthrin or Triumph Insecticide containing the organophosphate Isazofos were implicated. Tempo is a brand name owned by Bayer CropScience. Triumph Insecticide containing Isazofos was formally made by Syngenta. The patients' clinical course was marked by the rapid onset of vomiting, increased bronchial secretions, lacrimation, and salivation making the likely offending agent the Isazofos in the Triumph Insecticide. The child was treated with atropine at the local hospital, and became unresponsive. The child was intubated and flown to another hospital where she was treated with 2-PAM and remains on a ventilator. The initial symptoms of excess secretions resolved within the first 24 hours, though she continues to have respiratory compromise. The board certified medical toxicologist from the poison center completed a phone consultation with the child's treatment team, but no board certified medical toxicologist has seen the child at the hospital. Acetyl cholinesterase levels were recommended by the toxicologist with the consultation, but it is not clear if these labs have been drawn or what the results were. 6/3/2010 Callback to the poison center for follow up information. The child's condition has not changed since yesterday. A chest x-ray done this morning shows bilateral lung infiltrates and atelectasis. Thoracic physical therapy has been initiated to help with lung function. They are hoping to begin to wean her off of the ventilator tomorrow. 6/7/2010 Callback to the poison center for follow up information. The child remains on a ventilator, though is largely stable. Her vital signs and lab work are essentially normal. They attempted to extubate her on 6/4/2010 and 6/5/2010 without success. She would begin to develop respiratory distress within about 60 minutes of extubation, and was intubated again. Her lungs have coarse rales throughout and there is some evidence of scarring of the vocal cords according to the hospital. An ear, nose, and throat specialist will see the child in the next day or so prior to additional attempts to extubate. 6/9/2010 Callback to the treating hospital for follow up information. The child remains on a ventilator at this time, and continues to have ongoing respiratory issues as previously noted. Ear, nose, and throat specialist has not been in to see the child, and the consultation has been held until she is off of the ventilator.
To be determined by Registrant
14. Severity classification.
Major
