Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-1977
2. Registrant Information.
Registrant Reference Number: 2017CP017
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
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.
12-APR-17
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
09-APR-17
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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
Units: mL
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).
one tube was applied to dorsal midline of dog
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
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: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
- Skin
- Symptom - Edema
- Symptom - Erythema
4. How long did the symptoms last?
>30 min <=2 hrs / >30 min <=2 h
5. Was medical treatment provided? Provide details in question 13.
Yes
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)
Contact with treated area
Amount of time between application and contact 12
Hour(s) / Heure(s)
What was the activity? kissing the dog on the head
9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)
10. Route(s) of exposure.
Skin
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.)
a 28 kg, 13 year old female neutered canine Labrador retriever with no concomitant medical conditions , was applied one tube K9advantixII extra large dog once topically by the owner; the day after application, the pet owner kissed her dog on top of head and 20 minutes later she developed swelling and redness of her face; she took oral Benadryl and recovered 2 hours later;
To be determined by Registrant
14. Severity classification.
Moderate
15. Provide supplemental information here.