Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-1770
2. Registrant Information.
Registrant Reference Number: 35768
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.
21-APR-21
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. 29780
PMRA Submission No.
EPA Registration No.
Product Name: k9 advantix II large dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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 an unknown date in Feb-2021, a 1 year old, 24.1 kg, female spayed Bulldog in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 2.5 ML LGE DOG, KP0AHN2/ KP0AGB1 (-), by Animal owner. The product was used according to label (Yes).
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
Bulldog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
34.1
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Other
- Specify - Head Tremors
- Symptom - Muscle tremors
- Specify - Head Tremors
12. How long did the symptoms last?
<=30 min / <=30 min
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
An unknown time after application the dog experienced head tremors that lasted 4- 5 minutes.
On an unknown date in Mar 2021 1 tube K9 Advantix II large dog was applied to the same patient by animal owner. An unknown time later the dog experienced had tremors which lasted 4- 5 minutes.
On 01 Apr 2021 the dog was seen by a veterinarian who performed bloodwork. There were no abnormalities. The dog recovered on an unknown date.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here