Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-3773
2. Registrant Information.
Registrant Reference Number: 2014CK319
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
12-AUG-14
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
01-AUG-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: k9 advantix (unspecified)
7. b) Type of formulation.
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).
A 5yr mn cross breed dog was treated with K9 Advantix unspecified on approximately August 1st 2014.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
cross breed
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
Unknown
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
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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
Fully Recovered / Complètement rétabli
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
Shortly after product application (the same day), the dog became itchy at the application site. The pruritus persisted for 5 days before the dog was recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The owner reported that the reaction occurs after every product application. the dog receives the product monthly.