Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-5224
2. Registrant Information.
Registrant Reference Number: 201MA067
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.
Domestic Animal
4. Date registrant was first informed of the incident.
24-MAY-17
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
20-MAY-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. 29778
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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).
Owner applied a dose of K9 Advantix II for medium dog to a 12lbs 5.5yr dog.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Jack Russel
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5.5
7. Weight (provide a range if necessary )
5.45
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- General
- Symptom - Discomfort
- Specify - uncomfortable
- Skin
- Symptom - Itchy skin
- Symptom - Red skin
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Other / Autre
specify Unknown
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On May 20 an owner applied a dose of K9 Advantix II for medium dog to a 12lbs 5.5yr neutered male miniature poodle. Several hours later the dog was uncomfortable, itching at the application site and the skin was very red. The outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
B - Possible
Reported application site itching and reddening may reflect local dermal sensitivity to the product. Uncomfortable feeling is an unspecific sign and may have multiple potential other causes in a dog. However, it may represent a behavioural response to the product sensation. Considering short time to onset, a product connection is deemed to be possible.