Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-2104
2. Registrant Information.
Registrant Reference Number: 2015KP061
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Human
4. Date registrant was first informed of the incident.
17-APR-15
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
16-JUL-14
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: Advantage II unknown dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
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: 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).
On 20-Mar-2015, a (age) year old, boy, in good condition, with no known concurrent medical conditions, was exposed to an unknown amount of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) when he bathed with a dog that had the product applied on an unknown date. He bathed the dog with an oatmeal dog shampoo.
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: Male
Age: >6 <=12 yrs / > 6 < = 12 ans
3. List all symptoms, using the selections below.
System
- Skin
- Symptom - Erythema
- Symptom - Irritated skin
- Symptom - Pruritus
- General
- Symptom - Other
- Specify - Allergic reaction
- Symptom - Swelling
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)
Other
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.
Skin
11. What was the length of exposure?
Unknown / Inconnu
12. Time between exposure and onset of symptoms.
>30 min <=2 hrs / >30 min <=2 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.)
Approximately 1 hour after bathing the dog, the child exhibited red irritated, itchy skin on his face and facial swelling. The child was taken to the emergency room and diagnosed with an allergic reaction. The child was treated with prednisone, diphenhydramine, famotidine and cetirizine. The signs improved but worsened again when he was re exposed to the dog.
To be determined by Registrant
14. Severity classification.
Moderate
15. Provide supplemental information here.