Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-1061
2. Registrant Information.
Registrant Reference Number: 2018RB001
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.
11-JAN-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
17-OCT-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. 27586
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Large Cat
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
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 October 16, November 16, and December 16, 2017 a 5.1 kg, 13 year old cat with hyperthyroidism was treated for fleas with the application of Advantage II large cat.
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
Cat / Chat
3. Breed
unknown
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
13
7. Weight (provide a range if necessary )
5.1
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
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
Within 24 of hours of application on two occasions the cat vomited and recovered within 24 hours. An unknown time after the application of Advantage II large cat December 17, 2017 the cat developed a red, raised circular skin lesion that was not at the direct application site. The veterinarian clipped and assessed the area but no treatment was performed and thus this case is classified as minor.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
O - Unclassifiable/unassessable
Vomiting is an unspecific sign and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. However, short time to onset and thus a reaction to accidentally ingested product cannot be excluded. Skin lesions on other than the application site are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Time to onset consistent for initially reported vomiting, however inconsistent for skin lesion. Overall, a product involvement is unassessable.