Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-0753
2. Registrant Information.
Registrant Reference Number: 2015KP381
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.
15-JAN-16
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
17-NOV-15
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. 11556-155
Product Name: Seresto Collar Small Dog
- Active Ingredient(s)
- Flumethrin
- IMIDACLOPRID
- Guarantee/concentration 10 %
7. b) Type of formulation.
Other (specify)
Collar
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Other Units: Collar
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 17-Nov-2015, a women, of unknown signalment, in good condition, with no known concurrent medical conditions, was exposed to a dog that had a Seresto Small Dog (Flumethrin-Imidacloprid) collar removed prior to contact. The woman did not have direct contact with the Seresto collar.
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: Female
Age: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
- Nervous and Muscular Systems
- Symptom - Dizziness
- Symptom - Ataxia
- Symptom - Muscle weakness
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)
Contact with treated area
What was the activity? Contact with dog
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 / <=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.)
Immediately after handling the dog, the woman developed nausea, and dizziness. She washed her hands and arms with soap and water. The woman fell on the floor(muscle weakness) one minute later as she was walking. She remained dizzy on the floor for10 minutes. The woman recovered 16 hours post exposure.
To be determined by Registrant
14. Severity classification.
Major
15. Provide supplemental information here.
No exposure of the product is occurred as the collar was not on the animal at the time of handling of dog. Reported signs are not expected even after product exposure. Other unrelated causes must be considered. Time to onset after contact to dog short but product was already removed for an unknown time. Considering known product profile, a product relation is considered unlikely.