Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2019-0038
2. Registrant Information.
Registrant Reference Number: 2018RB191
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.
13-NOV-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
Unknown
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. 29777
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix II Small 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).
On 20 July 2018 the pet owner applied K9 Advantix II small dog to their 11 year old, 3 kg Yorkshire Terrier of unknown sex.
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
Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
3
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Hyperactivity
- Symptom - Irritable
- Specify - Irritability
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
An unknown time after application the dog became agitated, and scratched at the neck area where the product was applied and scratched at his ears. The symptoms resolved in 2 weeks. The product continued to be applied monthly and the dog continued to show signs of irritation.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
O - Unclassifiable/unassessable
Reported agitation and application site scratching may reflect paresthesia caused by permethrin. Scratching is not expected to be localized at ears but rather be linked to the application site. Other causes should be considered, e.g. allergies. Irritability is not expected either after topical product application and may have numerous other causes. Though application site involved, considering unknown time to onset and overall aspects, a product connection is unassessable.