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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-6221
2. Registrant Information.
Registrant Reference Number: 2023-CA-000366
Registrant Name (Full Legal Name no abbreviations): Evergreen Animal Health, LLC
Address: 22655 Centennial Road
City: Gretna
Prov / State: Nebraska
Country: USA
Postal Code: 68028
3. Select the appropriate subform(s) for the incident.
Human
4. Date registrant was first informed of the incident.
11-SEP-235. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
10-SEP-23Product 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: Parapet K9 Praventa 360 for dogs (non-specific) Spot-on
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
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?
No
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
- Eye
- Symptom - Pain
4. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
5. Was medical treatment provided? Provide details in question 13.
No
6. a) Was the person hospitalized?
No
6. b) For how long?
7. Exposure scenario
Non-occupational
8. How did exposure occur? (Select all that apply)
Application
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.
Skin
Eye
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.)
On 10-Sep-2023, a 60 year old, female human of unknown weight, with a concomitant medical condition of an allergy to penicillin, was exposed to an unknown amount of Parapet K9 Praventa 360 for dogs (non-specific) (Imidacloprid, Permethrin, Pyriproxyfen). This was an extra label use due to secondary exposure. While cutting open the applicator, the product immediately spilled onto the animal owner's hands. After applying the product to their dog, the individual washed their hands. Shortly after application, the individual developed left eye pain. They believed that they may have accidentally rubbed some product into their eye. On 11-Sep-2023, the clinical sign resolved without medical intervention.
To be determined by Registrant
14. Severity classification.
Minor
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 cannot 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.
